Suturing devices and methods for closing a patent foramen ovale

ABSTRACT

Methods and apparatuses are disclosed for closing a patent foramen ovale. Some of the disclosed apparatuses include an elongate body having a proximal end and a distal end, with first and second suture clasp arms adapted to hold end portions of a suture when in an extended position. A first suture catch mechanism is slidably housed in the elongate body and moves in a proximal-to-distal direction to engage the suture end held by the first suture clasp arm, and a second suture catch mechanism is slidably housed in the elongate body and moves in a distal-to-proximal direction to suture end held by the second suture clasp arm. The first suture clasp arm can be positioned around the septum primum to deliver a suture thereto, and the second suture clasp arm can be positioned around the septum secundum to deliver a suture thereto.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/908,946, filed Mar. 29, 2007, and U.S. Provisional Application No.60/981,468, filed Oct. 19, 2007, the entirety of both of which arehereby incorporated by reference.

BACKGROUND OF THE INVENTIONS

1. Field of the Invention

Embodiments of the present inventions relate to suturing devices andmethods. Specifically, preferred embodiments of the present inventionsrelate to suturing devices and methods for suturing a patent foramenovale.

2. Description of the Related Art

Health practitioners frequently use sutures to close various openingssuch as cuts, punctures, and incisions in various places in the humanbody. Because of their importance and frequent use, several types ofsutures and devices for their implantation and extraction have beendeveloped. These devices include needles having various shapes and sizesas well as devices for inserting and removing staples. Generally,sutures are convenient to use and function properly to hold openings inbiological tissue closed thereby aiding in blood clotting, healing, andprevention of scaring. However, there are some circumstances under whichit is not feasible to use conventional sutures and suturing methods toclose an opening. Some of these circumstances occur with incisions inarterial walls, or other internal bodily tissues. Here, catheter baseddevices and procedures have been suggested to close such openings.

For example, during development of a fetus in utero, blood is generallyoxygenated by the mother's placenta, not the fetus' developing lungs.Most of the fetus' circulation is shunted away from the lungs throughspecialized vessels or foramens, such as the foramen ovale. The foramenovale is a flaplike opening between the atrial septa primum and secundumwhich serves as a physiologic conduit for right to left shunting betweenthe atria. Typically, once the pulmonary circulation is establishedafter birth, left atrial pressure increases, resulting in the fusing ofthe septum primum and septum secundum and thus the closure of theforamen ovale. Occasionally, however, these foramen fail to close andcreate hemodynamic problems, which may ultimately prove fatal unlesstreated. A foramen ovale which does not seal is defined a patent foramenovale, or PFO.

To close such PFOs, open surgery may be performed to ligate and closethe defect. Such procedures are obviously highly invasive and posesubstantial morbidity and mortality risks. Alternatively, catheter-basedprocedures have been suggested which involve introducing expandablestructures through the patent foramen ovale to attempt to secure thetissue surrounding the patent foramen ovale, thereby blocking andsealing the patent foramen ovale. However, these structures involvesupport structures which may fail during the life of the patient and/orbecome dislodged, thereby re-opening the patent foramen ovale andpossibly releasing the structure within the patient's heart. Thus, itwould be advantageous to provide a simple, closure device and procedurefor sealing a patent foramen ovale.

SUMMARY OF THE INVENTIONS

Embodiments of the present inventions address the above problems byproviding a suturing device and method for suturing biological tissue,such as, for example, an organ or blood vessel. The device isparticularly well suited to suture a patent foramen ovale.

One embodiment relates to a suturing device comprising an elongate bodyand at least one arm, more preferably first and second arms. Each ofsaid arms has a suture mounting portion which mounts an end portion of asuture. The arms are mounted on the elongate body such that said suturemounting portions are movable away from said body to a first positionand towards said body to a second position. The suturing device furthercomprises at least one needle, and preferably first and second needles,each of said needles having a distal end. Each of said needles ismounted such that the distal end of the needle is movable from aposition adjacent said elongate body to a position away from said body,and towards the suture mounting portion of one of the arms when in saidfirst position, wherein the respective distal ends of the first andsecond needles engage respective end portions of said suture. Thesuturing apparatus further comprises an actuator which drives theneedles.

In one embodiment, a suturing apparatus comprises an elongate bodyhaving a proximal end and a distal end. A first suture clasp arm isadapted to hold an end portion of a suture, the first suture clasp armbeing extendable from the body from a retracted position to an extendedposition. A second suture clasp arm is adapted to hold an end portion ofa suture, the second suture clasp arm being extendable from the bodyfrom a retracted position to an extended position. A first suture catchmechanism is slidably housed in the elongate body, the first suturecatch mechanism being moveable in a proximal to distal direction toengage a distal end of the first suture catch mechanism with the sutureend held by the first suture clasp arm when the first suture clasp armis in the extended position. A second suture catch mechanism is slidablyhoused in the elongate body, the second suture catch mechanism beingmoveable in a distal to proximal direction to engage a distal end of thefirst suture catch mechanism with the suture end held by the secondsuture clasp arm when the second suture clasp arm is in the extendedposition.

In another embodiment, a suturing apparatus for suturing a patentforamen ovale comprises an elongate body having a proximal end and adistal end configured to be delivered percutaneously into the patentforamen ovale. At least a first suture clasp arm is adapted to hold afirst suture end portion. The first suture clasp arm is extendable fromsaid body from a retracted position to an extended position andconfigured to be placed around one of the septum primum and septumsecundum of the patent foramen ovale. At least a first suture catchmechanism is slidably housed in said elongate body. The first suturecatch mechanism is movable through one of the septum primum and septumsecundum of the patent foramen ovale to engage a distal end of the firstsuture catch mechanism with the first suture end portion held by thefirst suture clasp arm when the first suture clasp arm is in theextended position.

In another embodiment, a system for suturing a patent foramen ovalecomprises a first suturing apparatus and a second suturing apparatus.The first suturing apparatus comprises a first elongate body having aproximal end and a distal end, a first suture clasp arm adapted to holda first suture end portion, and a first suture catch mechanism slidablyhoused in said elongate body. The first suture clasp arm is extendablefrom said body from a retracted position to an extended position andconfigured to be placed around the septum primum of the patent foramenovale. The first suture catch mechanism is moveable in a proximal todistal direction through the septum primum of the patent foramen ovaleto engage a distal end of the first suture catch mechanism with thefirst suture end portion held by the first suture clasp arm when thefirst suture clasp arm is in the extended position. The second suturingapparatus comprises a second elongate body having a proximal end and adistal end, a second suture clasp arm adapted to hold a second sutureend portion, and a second suture catch mechanism slidably housed in saidelongate body. The second suture clasp arm is extendable from said bodyfrom a retracted position to an extended position and configured to beplaced around the septum secundum of the patent foramen ovale. Thesecond suture catch mechanism is moveable in a distal-to-proximaldirection through the septum secundum of the patent foramen ovale toengage a distal end of the second suture catch mechanism with the secondsuture end portion held by the second suture clasp arm when the secondsuture clasp arm is in the extended position.

In another embodiment, a suturing apparatus for suturing a patentforamen ovale comprises an elongate body having a proximal end and adistal end, a first suture clasp arm, a second suture clasp arm, a firstsuture catch mechanism, and a second suture catch mechanism. The firstsuture clasp arm is adapted to hold a first suture end portion. Thefirst suture clasp arm is extendable from said body from a retractedposition to an extended position and configured to be placed around theseptum primum of the patent foramen ovale. The second suture clasp armis adapted to hold a second suture end portion. The second suture clasparm is extendable from said body from a retracted position to anextended position and configured to be placed around the septum secundumof the patent foramen ovale. The first suture catch mechanism isslidably housed in said elongate body. The first suture catch mechanismis moveable in a proximal-to-distal direction through the septum primumof the patent foramen ovale to engage a distal end of the first suturecatch mechanism with the first suture end portion held by the firstsuture clasp arm when the first suture clasp arm is in the extendedposition. The second suture catch mechanism is slidably housed in saidelongate body. The second suture catch mechanism is moveable in adistal-to-proximal direction through the septum secundum of the patentforamen ovale to engage a distal end of the first suture catch mechanismwith the second suture end portion held by the second suture clasp armwhen the second suture clasp arm is in the extended position.

In another embodiment, a method of closing a patent foramen ovale havinga septum primum and a septum secundum is provided. An elongate body isadvanced into a tunnel of a patent foramen ovale. A first suture clasparm is extended from the elongate body from a retracted position to anextended position, the first suture clasp arm holding an end portion ofa suture. The first suture clasp arm is positioned around one of theseptum primum and the septum secundum. A first needle positioned in theelongate body is advanced outwardly from the body through tissue of oneof the septum primum and septum secundum and into engagement with thesuture end held in the first suture clasp arm. The first needle isretracted into the elongate body with the suture end carried by thefirst needle. A second suture clasp arm is extended from the elongatebody from a retracted position to an extended position, the secondsuture clasp arm holding an end portion of a suture. The second sutureclasp arm is positioned around the other of the septum primum and theseptum secundum. A second needle positioned in the elongate body isadvanced outwardly from the body through tissue of the other of theseptum primum and septum secundum and into engagement with the sutureend held in the second suture clasp arm. The second needle is retractedinto the elongate body with the suture end carried by the second needle.The elongate body is withdrawn from the tunnel of the patent foramenovale. The septum primum and the septum secundum are drawn closed.

In another embodiment, a method of closing a patent foramen ovale havinga septum primum and a septum secundum is provided. A first suture clasparm is positioned around one of the septum primum and the septumsecundum. The first suture clasp arm holds a first suture end portion. Afirst needle is advanced through tissue of one of the septum primum andseptum secundum and into engagement with the first suture end portionheld in the first suture clasp arm. The first needle is retractedthrough tissue of one of the septum primum and septum secundum with thefirst suture end portion carried by the first needle. A second sutureclasp arm is positioned around the other of the septum primum and theseptum secundum. The second suture clasp arm holds a second suture endportion. A second needle is advanced through tissue of the other of theseptum primum and septum secundum and into engagement with the secondsuture end portion held in the second suture clasp arm. The secondneedle is retracted through tissue of the other of the septum primum andseptum secundum with the second suture end portion. The septum primumand the septum secundum are drawn closed.

In another embodiment, a method of closing a patent foramen ovale havinga septum primum and a septum secundum is provided. A first elongate bodyis advanced into a tunnel of a patent foramen ovale. A first sutureclasp arm is extended from the first elongate body from a retractedposition to an extended position. The first suture clasp arm holds afirst suture end portion. The first suture clasp arm is positionedaround one of the septum primum and the septum secundum. A first needlepositioned in the elongate body is advanced outwardly from the bodythrough tissue of one of the septum primum and septum secundum and intoengagement with the first suture end portion held in the first sutureclasp arm. The first needle is retracted into the first elongate bodywith the first suture end portion carried by the first needle. The firstelongate body is withdrawn from the tunnel of the patent foramen ovale.A second elongate body is advanced near the tunnel of a patent foramenovale. A second suture clasp arm is extended from the second elongatebody from a retracted position to an extended position. The secondsuture clasp arm holds a second suture end portion. The second sutureclasp arm is positioned around the other of the septum primum and theseptum secundum. A second needle positioned in the second elongate bodyis advanced outwardly from the body through tissue of the other of theseptum primum and septum secundum and into engagement with the secondsuture end portion held in the second suture clasp arm. The secondneedle is retracted into the second elongate body with the second sutureend portion carried by the second needle. The second elongate body iswithdrawn from the tunnel of the patent foramen ovale. The septum primumand the septum secundum are drawn closed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a method of providing access to an exemplifying useenvironment, such as a patent foramen ovale.

FIG. 2A illustrates a side view of one embodiment of a suturing device.

FIG. 2B illustrates a side view of the distal end of the suturing deviceof FIG. 2A.

FIG. 2C illustrates a cross-sectional view of the elongate tubularmember of an embodiment of the suturing device taken along the line2C-2C of FIG. 2B.

FIG. 2D illustrates a cross-sectional view of the spreader assembly ofan embodiment of the suturing device taken along the line 2D-2D of FIG.2B.

FIG. 2E illustrates a cross-sectional view of the distal tip of anembodiment of the suturing device taken along the line 2E-2E of FIG. 2B.

FIG. 3 illustrates a side view of an embodiment of the suturing devicewith the suture clasp arms deployed.

FIG. 4A illustrates a perspective view of the suture clasp arms.

FIG. 4B illustrates a top plan view of an embodiment of a suture clasparm having one suture clasp.

FIG. 4C illustrates a top plan view of an alternative embodiment of asuture clasp arm having two suture clasps.

FIG. 5 is a side view of an embodiment of the suturing device showingsuture portions positioned in the suture clasp arms.

FIG. 6A illustrates a top plan view of an embodiment of a spreaderassembly showing a needle guide.

FIG. 6B illustrates a cross-sectional view of an embodiment of aspreader assembly showing proximal and distal needle guides.

FIG. 7A is a side view of an embodiment of a suture catch mechanism forengaging the proximal suture clasp arm.

FIG. 7B is a side view of an embodiment of a suture catch mechanism forengaging the distal suture clasp arm.

FIG. 8A is a side view of an embodiment of the suturing deviceillustrating the proximal and distal suture catch mechanisms in a storedposition.

FIG. 8B is a side view of an embodiment of the suturing deviceillustrating the proximal suture catch mechanism in a deployed position.

FIG. 8C is a side view of an embodiment of the suturing deviceillustrating the distal suture catch mechanism in a deployed position.

FIG. 9A is a perspective view of one embodiment of a handle of thesuturing device.

FIG. 9B is a perspective view of the handle of FIG. 9A, with a portionof the housing removed.

FIG. 10A is a schematic representation an embodiment of the suturingdevice deployed in a PFO.

FIG. 10B is a schematic representation as in FIG. 10A with the proximalsuture clasp arm positioned around the septum primum.

FIG. 10C is a schematic representation as in FIG. 10B showing theproximal needle engaging the proximal suture clasp arm.

FIG. 10D is a schematic representation as in FIG. 10C showing theproximal needle and suture portion retracted through the septum primum.

FIG. 10E is a schematic representation as in FIG. 10D with the distalsuture clasp arm positioned around the septum secundum.

FIG. 10F is a schematic representation as in FIG. 10E showing the distalneedle engaging the distal suture clasp arm.

FIG. 10G is a schematic representation as in FIG. 10F followingretraction of the distal needle and suture portion through the septumsecundum.

FIG. 10H is a schematic representation as in FIG. 10G showing the sutureportions positioned through the septum secundum and septum primum, andthe suturing device being withdrawn.

FIG. 10I is a schematic representation as in FIG. 10H showing the sutureportions positioned through the septum secundum and septum primumfollowing withdrawal of the suturing device.

FIG. 10J is a schematic representation of an alternative embodimentshowing the suture portions positioned through the septum secundum andseptum primum following withdrawal of the suturing device.

FIG. 10K is a schematic representation of an alternative embodimentshowing the suture portions positioned through the septum secundum andseptum primum following withdrawal of the suturing device.

FIG. 10L is a schematic representation of a patch being delivered to thePFO.

FIG. 11A is a schematic representation of an alternative embodimentshowing a suturing device with the distal clasp arm positioned aroundthe septum secundum.

FIG. 11B is a schematic representation showing the suturing device ofFIG. 11A with the distal needle engaging the distal suture clasp arm.

FIG. 11C is a schematic representation showing the suturing device ofFIG. 11A with the proximal clasp arm positioned around the septumprimum.

FIG. 11D is a schematic representation showing the suturing device ofFIG. 11A with the proximal needle engaging the proximal suture clasparm.

FIG. 11E is a schematic representation showing the suture portionsdeployed following the steps of FIGS. 11A-11D.

FIG. 12A is a schematic representation of an alternative embodiment of asuturing device being delivered through a tunnel of the PFO.

FIG. 12B is a schematic representation of the suturing device of FIG.12A showing a distal suture clasp arm engaging the septum secundum.

FIG. 12C is a schematic representation of the suturing device of FIG.12A showing the distal needle engaging the distal suture clasp arm.

FIG. 12D is a schematic representation of the suturing device of FIG.12A showing the distal needle retracted from the septum secundum.

FIG. 12E is a schematic representation of the suturing device of FIG.12A showing the suturing device partially withdrawn from the tunnel ofthe PFO and the suture clasp arms retracted into the device.

FIG. 12F is a schematic representation of the suturing device of FIG.12A showing the suturing device advanced further into the left atriumwith the proximal and distal suture clasp arms extended from thesuturing device.

FIG. 12G is a schematic representation of the suturing device of FIG.12A showing a proximal suture clasp arm engaging the septum primum.

FIG. 12H is a schematic representation of the suturing device of FIG.12A showing the proximal needle engaging the proximal suture clasp arm.

FIG. 12I is a schematic representation of the suturing device of FIG.12A showing the proximal needle retracted from the septum primum.

FIG. 12J is a schematic representation of the suturing device of FIG.12A showing the suturing device advanced further into the left atrium.

FIG. 12K is a schematic representation of the suturing device of FIG.12A showing the suture clasp arms retracted into the suturing device.

FIG. 12L is a schematic representation of the suturing device of FIG.12A showing the suturing device being withdrawn from the PFO.

FIG. 13 illustrates a side view of one embodiment of a suturing device.

FIG. 14A illustrates a side view of the distal end of the suturingdevice of FIG. 13.

FIG. 14B illustrates a side view of a distal end of a suturing device ofone embodiment.

FIG. 15A illustrates a cross-sectional view of the elongate tubularmember of an embodiment of the suturing device of FIGS. 13 and 14A,taken along the line 15A-15A of FIG. 14A.

FIG. 15B illustrates a cross-sectional view of the elongate tubularmember of an embodiment of the suturing device of FIG. 14B, taken alongthe line 15B-15B of FIG. 14B.

FIG. 16 illustrates a perspective view of a spreader assembly of anembodiment of the suturing device.

FIG. 17 illustrates another perspective view of the spreader assembly ofFIG. 16.

FIG. 18A illustrates a cross-sectional view of a distal end of anelongate tubular member, the spreader assembly of FIGS. 16 and 17, and ahousing taken along the line 18-18 of FIG. 15A.

FIG. 18B illustrates a cross-sectional view of a distal end of anelongate tubular member, a spreader assembly, and a housing showingfeatures for limiting the range of travel of suture catch mechanisms.

FIG. 19 illustrates a side view of an embodiment of the suturing devicewith the suture clasp arms deployed and various internal features shownin phantom.

FIG. 20 illustrates a perspective view of a suture clasp arm.

FIG. 21 illustrates a perspective view of a suture clasp arm.

FIG. 22 illustrates a cross-sectional view of a suture clasp arm and aneedle.

FIG. 23 illustrates a perspective view of the suture clasp arm and theneedle of FIG. 22.

FIG. 24 illustrates a perspective view of a housing of an embodiment ofthe suturing device.

FIG. 25 illustrates another perspective view of the housing of FIG. 24.

FIG. 26 illustrates a top view of a distal end of an embodiment of asuturing device with various features shown in phantom lines.

FIG. 27 is a perspective view of one embodiment of a handle of thesuturing device.

FIG. 28A is a cross-sectional view of the handle of FIG. 27 taken alongthe line 28A-28A shown in FIG. 27.

FIG. 28B is a cross-sectional view of the handle of FIG. 27 taken alongthe line 28B-28B shown in FIG. 27.

FIG. 29A is a schematic representation an embodiment of the suturingdevice deployed in a PFO.

FIG. 29B is a schematic representation as in FIG. 29A with a distalsuture clasp arm positioned around the septum primum.

FIG. 29C is a schematic representation as in FIG. 29B showing theproximal needle engaging the distal suture clasp arm.

FIG. 29D is a schematic representation as in FIG. 29C showing theproximal needle and suture portion retracted through the septum primum.

FIG. 29E is a schematic representation as in FIG. 29D showing thesuturing device positioned to permit a proximal suture clasp arm toextend from the suturing device.

FIG. 29F is a schematic representation as in FIG. 29E with the proximalsuture clasp arm positioned around the septum secundum.

FIG. 29G is a schematic representation as in FIG. 29F showing the distalneedle engaging the proximal suture clasp arm.

FIG. 29H is a schematic representation as in FIG. 29G followingretraction of the distal needle and suture portion through the septumsecundum.

FIG. 29I is a schematic representation as in FIG. 29H showing the sutureportions positioned through the septum secundum and septum primum, andthe suturing device being withdrawn.

FIG. 29J is a schematic representation as in FIG. 29D showing thesuturing device of FIGS. 14B and 15B positioned to permit the proximalsuture clasp arm to extend from the suturing device and a second guidewire extended.

FIG. 29K is a schematic representation as in FIG. 29J with the proximalsuture clasp arm positioned around the septum secundum.

FIG. 29L is a schematic representation as in FIG. 29K showing the distalneedle engaging the proximal suture clasp arm.

FIG. 29M is a schematic representation as in FIG. 29L followingretraction of the distal needle and suture portion through the septumsecundum.

FIG. 30 is a perspective view of one embodiment of a handle of a knotplacement device.

FIG. 31 is a cross-sectional view of the handle of FIG. 30 taken alongthe line 31-31 shown in FIG. 27.

FIG. 32 is a cross-sectional view of a distal end of a knot placementdevice.

FIG. 33 is a perspective view of one embodiment of a handle of asuturing device.

FIG. 34A is a cross-sectional view of the handle of FIG. 33 taken alongthe line 34A-34A shown in FIG. 33.

FIG. 34B is a cross-sectional view of the handle of FIG. 33 taken alongthe line 34B-34B shown in FIG. 33.

FIG. 35 is a side view of an actuator and a follower of the handle ofFIG. 33.

FIG. 36 is a side view of one embodiment of a system of suturingdevices.

FIG. 37 is a perspective view of a distal end of a first suturing deviceof the system of FIG. 36.

FIG. 38 is a perspective view of a distal end of a second suturingdevice of the system of FIG. 36.

FIG. 39A is a schematic representation an embodiment of the firstsuturing device of the FIG. 37 deployed in a PFO.

FIG. 39B is a schematic representation as in FIG. 39A with a sutureclasp arm positioned around the septum primum.

FIG. 39C is a schematic representation as in FIG. 39B showing a needleengaging the suture clasp arm.

FIG. 39D is a schematic representation as in FIG. 39C showing the needleand suture portion retracted through the septum primum.

FIG. 39E is a schematic representation as in FIG. 39D showing the secondsuturing device of FIG. 38 positioned to permit a suture clasp arm toextend from the second suturing device and a second guidewire extended.

FIG. 39F is a schematic representation as in FIG. 39E with the sutureclasp arm positioned around the septum secundum.

FIG. 39G is a schematic representation as in FIG. 39F showing a needleengaging the suture clasp arm.

FIG. 39H is a schematic representation as in FIG. 39G followingretraction of the needle and suture portion through the septum secundum.

FIG. 39I is a schematic representation as in FIG. 39H showing the sutureportions positioned through the septum secundum and septum primum, andthe second suturing device being withdrawn.

FIG. 39J is a schematic representation as in FIG. 39I showing the sutureportions being joined by a first knot following withdrawal of thesuturing device.

FIG. 39K is a schematic representation as in FIG. 39J showing the firstknot being positioned between the septum secundum and septum primum.

FIG. 40A is a schematic representation as in FIG. 39D showing the secondsuturing device positioned to permit the suture clasp arm to extend fromthe second suturing device and the second guide wire extended throughthe PFO.

FIG. 40B is a schematic representation as in FIG. 40A with the sutureclasp arm positioned in the PFO around the septum secundum.

FIG. 40C is a schematic representation as in FIG. 40B showing the needleengaging the suture clasp arm.

FIG. 40D is a schematic representation as in FIG. 40C followingretraction of the needle and suture portion through the septum secundum.

FIG. 40E is a schematic representation as in FIG. 40D showing the sutureportions positioned through the septum secundum and septum primum, andthe second suturing device being withdrawn.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments of the present invention provide suturing devices andmethods for closing an opening in biological tissue, a body lumen,hollow organ or other body cavity. The suturing devices and theirmethods use are useful in a variety of procedures, such as treating(closing) wounds and naturally or surgically created apertures orpassageways. For example, the suturing devices may be used to seal anopening in the heart wall such as an atrial septal defect, a patentductus arteriosis or a patent foramen ovale. In addition, the suturingdevices may be used to close or reduce a variety of other tissueopenings, lumens, hollow organs or natural or surgically createdpassageways in the body. Also, the suturing devices may be used tosuture prosthetics, synthetic materials, or implantable devices in thebody. For example, the devices may be used to suture pledget within thebody.

FIG. 1 illustrates one embodiment in an exemplifying use environment forclosing a patent foramen ovale (PFO). Adaption of the devices andmethods disclosed herein for closing a PFO may also be made with respectto procedures for closing other bodily tissue openings, lumens, holloworgans or natural or surgically created passageways and procedures forsuturing prosthetics, synthetic materials, or implantable devices in thebody. As depicted by FIG. 1, a guidewire 10 is advanced into the rightatrium 2 of the heart 9 through the inferior vena cava 3. It isanticipated that the heart may be accessed through any of a variety ofpathways, such as through the inferior vena cava 3 via a femoral accesssite, through the superior vena cava 5 via the subclavian or jugularveins, or any other venous or arterial access sites. The guidewire 10can then be further positioned in the tunnel or opening of the patentforamen 8 ovale between the septum primum 7 and septum secundum 6. Withthe guidewire 10 in place, the physician can insert a sheath 11 to theright atrium. This sheath 11 is typically a single lumen catheter with avalve on its proximal end. The valve is used to prevent extraneous bleedback or to introduce medication into the patient's body. The sheath 11can be placed at or near the tunnel of a patent foramen ovale 8. Thesuturing device 100, described further below, can then be advanced tothe PFO 8 through the lumen of the sheath 11. In an alternativeembodiment, the suturing device 100 can be advanced over the guidewire10 and positioned in the opening of the patent foramen ovale 8 withoutthe need to insert an introducer 11. Other methods of accessing the PFOor other bodily locations.

FIG. 2A shows one embodiment of the suturing device 100 for suturing anopening in a vessel wall and other biological tissue. While the devicewill be described in reference to suturing an opening in the heart wallsuch as a patent foramen ovale (PFO), the device could be used to closeother openings in the heart wall, such as a patent ductus arteriosus(PDA) or an atrial septal defect (ASD), other puncture wounds in bodilytissue, or the like, or to perform other procedures as described above.The suturing device 100 comprises an elongated tubular member 20 havinga spreader assembly 30 (shown in FIG. 2B) connected to the distal end ofthe elongated tubular member 20 for positioning in the opening of thePFO. A handle 200 is provided at the proximal end of the tubular member20. The axial length and flexibility of the elongated tubular member 20is sufficient to percutaneously access the patient's vasculature andadvance the elongate tubular member 20 through the venous system to thepatient's heart with the proximal end of the device remaining outsidethe patient's body. However, the length of the device may vary dependingupon the intended access point and pathway to the heart. For example,for a femoral access point and pathway via the inferior vena cava, theaxial length of the elongate tubular member 20 can be between about70-120 cm, alternatively between about 80-100 cm, alternatively about 90cm.

As shown in more detail in FIG. 2C, the elongate tubular member 20 has aplurality of lumens extending along the axial length. The multi-lumenelongate tubular member 20 can be manufactured in accordance with any ofa variety of techniques known to those skilled in the art. For example,in some embodiments, the elongate tubular member 20 can be formed from amulti-lumen extruded plastic tubing, such as a polyester, polyethelyne,polymide, nylon or any other suitable material known to those skilled inthe art. The elongate tubular member 20 comprises four central lumens21, 22, 23 and 24 vertically stacked along a central axis of theelongate tubular member 20. In some embodiments, the central lumens maybe surrounded by two semicircular or D-shaped lumens 25 and 26 extendingaxially on opposite sides of the elongate tubular member 20. In someembodiments, as will be discussed below in more detail, the centrallumens 21, 22, 23, and 24 will be used to provide access through theelongate tubular member 20 for a guidewire, to provide access for anactuating rod connected to the suture clasp arms, and to house one ormore suture catch mechanisms or needles. The semi-circular shaped lumens25 and 26 can be used to deliver one or more sutures to the distal endof the elongate tubular member 20.

The spreader assembly 30 is bonded, or otherwise joined, to the distalend of the elongated tubular member 20, for example with epoxy or anyother suitable technique known to those skilled in the art.Alternatively, the spreader assembly may be integral with the elongatetubular member 20 As shown in FIG. 2D, the spreader assembly comprisescentral lumens 131, 132, 133 and 134 vertically stacked along a centrallongitudinal axis of the spreader assembly 30. When the spreader 30 andthe elongate tubular member are properly connected, the central lumens21, 22, 23 and 24 of the elongate tubular member 20 and the centrallumens 131, 132, 133 and 134 of the spreader assembly 30 are preferablysubstantially aligned to provide continuous passageways through theelongate tubular member 20 and spreader assembly 30. A metal casing, orbullet, 40, having a length greater than the length of the spreader 30and an inner diameter substantially the same as the outer diameter ofthe spreader assembly 30 and elongate tubular member 20 is placed overthe connection between the elongate tubular member 20 and the spreaderassembly 30 to maintain the proper alignment of the internal lumens ofthe elongate tubular member 20 and spreader assembly 30. The bulletcomprises openings 41A and 41B located on the opposite sidewalls of thebullet 40 for allowing the release and deployment of suture clasp armshoused within the spreader assembly 30. Accordingly, the openings 41Aand 41B are sized and shaped to permit the suture clasp arms to fullyextend from the spreader assembly 30.

In some embodiments, the bullet 40 has a length such that when theproximal end of the bullet is positioned over the connection between thespreader assembly 30 and the elongate tubular member 20, its distal endextends beyond the distal end of the spreader assembly 30. A distal tip70 which may be rounded or atraumatic can be bonded or adhered to thedistal end of the spreader assembly 30, for example with epoxy or anyother suitable technique known to those skilled in the art. As shown inFIG. 2E, the distal tip can have at least one central lumen 172 that isaxially aligned with a central lumen 132 of the spreader 30 and acentral lumen 22 of elongate tubular member 20 for providing acontinuous passageway through the entire length of suturing device 100,for example for a guidewire. In addition, the distal tip 70 may have oneor more additional lumens 173 that can be aligned with lumens in thespreader assembly 30 and elongate tubular member 20 to provideadditional continuous passageways, for example for housing a suturecatch mechanism. Here, as discussed above, the outer diameter of thedistal tip is substantially the same size as the inner diameter of thebullet 40 such that when the distal end of the bullet 40 is positionedover the connection between the distal tip 70 and the spreader assembly30, the bullet maintains the proper alignment of the internal lumens ofthe distal tip 70 and spreader assembly 30.

As shown in FIG. 2B, a pair of suture clasp arms 31A and B are housed inrecesses 41A and 41B in the central portion of the spreader assembly 30.During storage and delivery of the suturing device, the suture clasparms 31A and 31B are situated parallel to the longitudinal axis of thesuturing device such that the outer walls of the suture clasp arms donot extend beyond the outer diameter of the spreader assembly 30. Afterinsertion and positioning of the suturing device at the PFO or otheropening, the arms 31A and B can be deployed to the position shown inFIG. 3. To deploy the suture clasp arms, the suture clasp arms 31A and Bare connected to an actuating rod 35 which extends through thepassageway formed by lumen 134 in the spreader assembly and centrallumen 24 in the elongate tubular member 20. For example, in certainembodiments, the proximal suture clasp arm 31A and the distal sutureclasp arm 31B may be manufactured as a single component, or alternatelyfixedly connected at a central connection point. Here, the distal end ofthe actuating arm 35 may be connected to the distal suture clasp arm31B, offset from the middle, or central connection point, of the sutureclasp arms such that proximal retraction of the actuating arm 35 willpull on the distal suture clasp arm 31B creating a counterclockwisetorquing force on the suture clasp arms which will cause both sutureclasp arms 31A and B to flip out from the spreader assembly 30.

When deployed, the suture clasp arms 31A and B extend from the suturingdevice 100 in opposite directions along the longitudinal axis of thedevice. Preferably, the arms 31A and 31B form an acute angle with thelongitudinal axis of the spreader. In some embodiments, a first arm 31Aextends outward toward the proximal end of the spreader assembly 30 atan angle of between about 35-55°, alternatively about 40-50°,alternatively about 45° with respect to the longitudinal axis of thespreader assembly 30, while the second arm 31B extends outward towardthe distal end of the spreader assembly 30 at the same angle as thefirst arm 31A with respect to the longitudinal axis of the spreaderassembly 30.

As shown in FIG. 3, the suture clasp arms 31A and 31B may be deployedsimultaneously to extend equally in opposite directions with respect tothe suturing device. In some embodiments, the suture clasp arms 31A andB can be independently actuated to be individually deployed dependingupon the location of the tissue portion to be sutured. However, in someembodiments, it may be advantageous to simultaneously deploy both sutureclasp arms 31A and B, even though only one of the suture clasp arms willbe engaged at that location. For example in closing a PFO, the suturingdevice will first be positioned with respect to a first tissue portionto be sutured and then moved to a second position for suturing a secondtissue portion. However, the second suture clasp arm 31B can still bedeployed at the first location to provide mechanical support andstabilization for positioning the first suture clasp arm 31A proximal tothe first tissue portion. For example, as shown in FIG. 10B, whenclosing a PFO, the suturing device 100 is first positioned such thatsuture clasp arm 31A extends around the septum primum 7 such that sutureportion 52A may be engaged and pulled though the septum primum 7 to drawit toward the septum secundum 6. Here, the non-engaged suture clasp arm31B is still extended toward and contacts the septum secundum 6 whichpushes the suturing device 100 toward the septum primum 7 therebyassisting in placement of the suture clasp arm 31A around the septumprimum 7 and stabilizing the suturing device 100 during deployment ofthe suture catch mechanism to engage the suture.

As shown in FIG. 5, each of the suture clasp arms 31A, 31B has a sutureclasp 33 for receiving and holding a suture 50. The suture clasp 33 canbe a circular opening with a diameter sized to securely receive and holda loop of suture 50. For example, as described in U.S. Pat. No.6,562,052, the entirety of which is hereby incorporated by reference,the suture can comprise a length of suture 50 having a loop formed ateach end of the suture. Other details regarding the apparatuses andmethods of suturing devices that may be utilized with the embodimentsdisclosed throughout this specification are also found in U.S. Pat. No.6,562,052 and are hereby incorporated by reference. The diameter of thesuture loops and the inner diameter of the suture clasp 33 arepreferably substantially the same such that the suture loops can besecurely positioned in the suture clasp 33 during deployment of thesuture clasp arms. The suture clasp 33 is advantageously angled suchthat when the suture clasp arm is deployed at an angle, the suture clasp33 will hold the suture loop perpendicular to the path of the suturecatch mechanism. In some embodiments, the suture clasp arm 31 can have atab or slot 34 located on the distal end of the suture clasp arm 31 forguiding the suture loop into the suture catch 33 at the proper angle.

In use, as shown in FIG. 5, the suture 50 can be housed in one of theouter D-shaped, or suture, lumens 25, 26 of the elongate tubular member20. The suture lumen 26 has a port or opening 42 on the distal end ofthe elongate tubular member 20. The suture 50 can be advanced throughthe opening 42 such that the suture ends, or end portions 52A and 52B,extend outside of the suturing device 100. One of the suture endportions 52A may extend from the opening 42 to the suture clasp arm 31A.The other suture end portion 52B may extend along the length of thebullet and into a side opening 71 in the distal tip 70. The sutureportion 52B may extend out of a distal opening 73 in the distal tip, andthen loop back into the opening 73. The suture end portion 52B thenextends through side opening 71 to the suture clasp arm 31B.

The suture ends are positioned in the suture clasps 33A and 33B of thesuture clasp arms 31A and 31B and held securely there until they areengaged and removed by a suture catch mechanism. As discussed above, thesuture clasp arms 31A and 31B comprise slots 34A and 34B to guide thesuture into the suture clasps 33 at the proper angle and assist inmaintaining the suture loops in the suture clasp until they are engagedby the suture catch mechanisms. When the suture catch mechanism engagesthe loops of the suture ends, the suture loops will slide out of thesuture clasp 33 and be released by the suture clasp arm 31.

In some embodiments, the suture clasp arms 31A and 31B may furthercomprise additional suture clasp(s) for holding additional sutureportions. For example, in an alternative embodiment, shown in FIG. 4C,each suture clasp arm can be configured to deploy two sutures from thesuturing device to a particular location for suturing a single tissueportion. Here, each suture clasp arm 431 has two suture clasps 433A and433B for receiving two different suture portions 150 and 151. Inaddition, in some embodiments, each suture clasp arm can further includetwo slots 434A and 434B for guiding the suture portions 150 and 151 intothe suture clasps 433A and 433B.

As shown in more detail in FIGS. 6A-B, the spreader assembly 30 includesa plurality of needle guides 60A and 60B for guiding a plurality ofsuture catch mechanisms, such as a needle or other penetratingmechanism, towards the deployed suture clasp(s). In one embodiment, thespreader assembly 30 may comprise two needle guides 60A and 60B locatedon the distal and proximal ends of the spreader assembly for guiding twoneedles toward proximally and distally deployed suture arms 31A and 31Bdepicted in FIG. 3. Each of the needle guides 60A and 60B comprises anangled groove or channel in the sidewall of the spreader assembly 30such that it will deflect a suture catch mechanism, or needle, exitingthe suture assembly 30 along a path that intercepts the suture clasps33A and 33B of the suture clasp arms when the suture clasp arms 31A and31B are in a deployed position. For example, in some embodiments, thesuture arms 31A and 31B may be sized such that a groove having an angleof between about 10-35°, alternatively about 15-25°, alternatively about19° with respect to the longitudinal axis of the spreader assembly willspread the needles to the proper angle to engage the suture loops in thedeployed suture clasps 33. In use, the proximal needle guide 60A isaligned with lumen 131 of the spreader assembly and lumen 21 of theelongate tubular member such that when a suture catch mechanism isadvanced through the passageway formed by lumens 131 and 21, the distalend of the needle will be deflected by the needle guide 60A towards thedeployed suture clasp arm 31A. Likewise, distal needle guide 60B isaligned with lumen 173 of the distal tip such that when the distal tipof a needle housed in lumen 173 is extended towards suture clasp arm31B, the needle will be deflected toward the suture clasp 33.

In some embodiments, as depicted in FIG. 7A, the suture catch mechanism161 which is configured for engaging the suture clasp arm 31A extendingtoward the proximal end of the spreader assembly 30 comprises anelongate, straight needle 161. As shown in FIG. 7A, the needle 161 has asharp, distal tip 163 for penetrating a tissue portion positionedbetween the suturing device and the deployed suture clasp arm 31A and anotch or groove 162 on the distal tip 162 for engaging the loop ofsuture portion 52A held by suture clasp 33. The notch or groove 162 isshaped or angled upward in order to grasp and dislodge the loop from thesuture clasp 33 and retain the suture portion 52A against the groove 162as the needle is pulled back through the suture clasp 33 and tissueportion and retracted back into the suturing device 100.

As shown in FIG. 7B, suture catch mechanism 165, which is configured toengage a suture clasp arm 31B extending towards the distal end of thespreader assembly 30 comprises an elongate needle 165 having a distalportion 166 bent approximately 180 degrees such that a portion of theneedle is turned back upon itself. The turned portion 166 of the needle165 has a length sufficient to extend from the spreader assembly 30 andengage the suture clasp 33B on suture clasp arm 31B when suture clasparm 31B is in a fully deployed position. Similar to elongate, straightneedle 161, the turned back portion 166 has a sharp distal tip 167 forpenetrating a tissue portion positioned between the suturing device andthe deployed suture clasp arm 31B and a notch or groove 168 on thedistal tip 167 for engaging a loop of suture help by suture clasp arm31B. The notch or groove 168 on the needle is configured to grasp andretain the loop of suture portion 52B from the suture catch 33B as theturned portion 166 of the needle 165 (FIG. 8B) is conveyed through thetissue portion and retracted back into the groove 173 (FIGS. 8B and 8C)of the distal tip 70 of the suturing device 10.

The needles 161 and 165 are flexible and are preferably made of amaterial with shape memory, such as nickel titanium or NITINOL.Alternatively, the needles 161 and 165 may be comprised of spring steel,surgical stainless steel or any variation thereof.

In use, as shown in FIG. 8A, the needles 161 and 165 can be housedwithin a central passageway formed by lumens within the elongate tubularmember, spreader assembly and distal tip. Here, suture catch mechanism161 is slidably housed in the passageway formed by the central lumens 21of the elongate tubular member 20 and central lumen 131 of the spreaderassembly while suture catch mechanism 165 is slidably housed in thepassageway formed by central lumen 23 of the elongate tubular member,central lumen 133 of the spreader assembly and lumen 173 of the distaltip 70.

As shown in FIG. 8B, for suture arm 31A extending outward toward theproximal end of the spreader assembly 30, the proximal end of the needleguide 60A is aligned with a lumen 131 (see FIG. 2B) extending though thespreader assembly 30 such that when needle 161, or other suture catchmechanism, is advanced through the passageway formed by central lumen 21in the elongate tubular member 20 and central lumen 131 in the spreaderassembly 30, the distal end of the needle will exit the suturing devicethrough central lumen 131 and be advanced along the groove of the needleguide 60A. The needle guide 60A then deflects the distal end of needle161 outward along the angle of the groove to penetrate suture clasp 33Aon the suture clasp arm 31A and engage the suture portion 52A held bythe suture clasp 33A. Once the needle 161 has engaged the suture portion52A, the needle 161 may be retracted back into central lumen 131 alongwith the suture portion 52A held by groove 162 on the distal end ofneedle 161. (See FIG. 8C.)

As shown in FIG. 8C, for suture arm 31B, extending outward toward thedistal end of the spreader assembly in a deployed position, the distalend of needle guide 60B is aligned with a lumen 173 in the distal tip ofthe suturing device. Here, before insertion, the needle 165 has beenadvanced through central lumen 123 in the elongate tubular member beyondthe spreader assembly 30 and positioned a slot or cavity 173 within thedistal tip 70 of the suturing device that has been aligned with thecentral lumen 123 of the elongate tubular member. The cavity 173 has adiameter sized to receive the distal end of the needle 165, includingthe turned portion 166. The turned portion 166 is positioned in cavity173 such that the distal tip 167 is aligned with the needle guide 60Blocated on the distal end of the spreader assembly 30. Thus, in use,when the proximal end of the needle 165 is pulled back through thecentral lumen 123 of the elongate tubular member 20, the turned portion166 of the needle will be advanced along the groove of the needle guide60B and deflected outward along the angle path of the groove topenetrate the deployed suture clasp 33B on the suture clasp arm 31B andengage suture portion 52B held therein. Once the needle 165 has engagedthe suture portion 52B, the proximal end of the needle 165 may then bepushed forward through the central lumen 123 of the elongate tubularmember which will cause the bent portion 166 of the needle to beretracted along needle guide 60B into cavity 173 along with the sutureportion 52B held by the groove 168 on the distal end of the needle 165.

In some embodiments, as discussed above, the suture catch assembly cancomprise two suture catch mechanisms, or needles housed on oppositesides of the elongate tubular member 20 for engaging the two sutureclasp arms. The needles may be independently actuated such that theneedles may be independently deployed. In an alternative embodiment, thesuture catch assembly may comprise four needles, for example two needleshoused on each side of the elongate tubular member for engaging multiplesuture portions in each of the suture clasp arms. Here, each of theneedles may be independently actuated or alternatively both needles forengaging a single suture clasp arm may be jointly actuated such thatthey are deployed at the same time.

Referring now to FIGS. 9A-9B, the proximal end of the needles 161 and165 extend through the central lumens 21 and 23 of the elongate tubularmember and terminate at a connection to actuating levers 210 and 216 onthe suturing device handle 200. The handle 200 includes a housing 201which is attached to the proximal end of the elongate tubular member 20.The housing 201 has an aperture 202 providing a passageway between thehandle 200 and the multiple lumens of the elongate tubular member 20.One or more levers or buttons 210, 216, 240 and 250 may extend from thehousing 201. The levers or buttons 210, 216, 240 and 250 can beconnected to actuating rods or mechanisms for deploying and/orretracting the suture clasp arms and suture catch mechanisms moveablyhoused in the suturing device.

With reference to FIGS. 9A-9B, in some embodiments, the handle 200 canhave two actuating levers 210 and 216 for deploying and retracting thesuture catch mechanisms such as needles 161 and 165 of the suturingdevice. For example, in one embodiment, the proximal end of needle 165extends from the proximal end of central lumen 23 in the elongatetubular member through opening 202 into the handle 200 and is insertedinto an opening 211 in a lever needle holder 212. The needle 165 may besecurely connected to opening 211 in the lever needle holder 212 byfriction fit in the opening 211, by bonding with epoxy, or any othersuitable technique know to those in the art. The lever needle holder 212is permanently connected to a needle deployment lever 210 extending fromthe handle housing 201, such that in use, when the physician pushes thelever forward or pulls the lever back, the needle deployment lever 210will advance or retract the needle holder 212 longitudinally along anaxis of the handle 200 and thus advance or retract the attached needle163 longitudinally within the lumen 23 of the elongate tubular member20. The housing 200 comprises a fixed length opening 213 surrounding theneedle lever 210 which provides a limit to the distance the needle 163can be advanced or retracted by limiting the distance over which thelever 210 can be pushed or pulled. In general, the axial length of theopening 213 should be sufficient to permit the turned distal end of theneedle 163 to be extended from a pre-deployment position within thesuturing device 100 to engage the distal suture clasp arm 31A in a fullydeployed position, as discussed above. However, limiting the distancethe needle can be deployed may advantageously prevent the needle frombeing advanced too far and potentially puncturing adjacent tissue.

The proximal end of needle 161 is likewise configured to extend throughcentral lumen 21 of the elongate tubular member 20 and is inserted intoan opening 214 in a lever needle holder 215. The lever needle holder 215is permanently connected to a second needle deployment lever 216extending from the handle housing 201, such that in use, when thephysician pushes the lever forward or pulls the lever 216 back, theneedle deployment lever 216 will advance or retract the needle holder215 and thus advance or retract the attached needle 161. The housing 201comprises a fixed length opening 217 surrounding the needle lever 216which provides a limit to the distance the needle 161 can be advanced orretracted by limiting the distance over which the lever 216 can bepushed or pulled. In general, the axial length of the opening 217 shouldbe sufficient to permit the distal end of the needle 161 to be extendedfrom a pre-deployment position within the elongate tubular member 20 toengage the proximal suture clasp arm 31A in a fully deployed position,as discussed above.

Deployment of the suture claps arms 31A and 31B can be performed bydepressing a button 240 located on the handle 200. The button 240 may beconnected to an arm puller mechanism 241 which is configured to beextended and retracted along a longitudinal axis of the handle 200,which is operably connected to actuating rod 35. For example, in someembodiments, the arm puller mechanism may have a slot configured toreceive the proximal end of the actuating rod 35.

The actuating rod 35 extends through central lumen 24 of the elongatetubular member 20 and is connected to the suture clasp arms 31 such thatproximal retraction of the actuating rod 35 causes the suture clasp arms31A and B to extend from the spreader assembly 30. For example, asdiscussed above, in some embodiments, the actuating rod 35 can beconnected to the distal suture clasp arm 31B at a location that causesthe suture clasp arms 31A and 31B to swing out from the spreaderassembly 30 in a counter-clockwise direction. In use, when button 240 isdepressed, the arm pull mechanism 241 is pulled back against spring 251causing the actuating rod 35 to be retracted though central lumen 24,thus deploying the suture clasp arms. When button 240 has beencompletely depressed, the button 240 engages a lip 245 of the arm pullermechanism 241 and maintains the arm puller mechanism 241 in a locked,retracted position compressing spring 251. A second button 250 islocated on handle 200, proximal to button 240. Button 250 has a lever252 extending within the housing 201 which is configured to engage anedge of button 240 and raise the button 240 from lip 245 of the armpuller mechanism. Once the arm puller mechanism 241 has been released,spring 251 may expand to an uncompressed state, thereby pushing the armpuller mechanism 241 forward. Forward motion of the arm puller mechanismadvances the attached actuating rod 135 which transmits a clockwiserotational force to the suture clasp arms causing the suture clasp armsto be retracted within the spreader assembly 30. Further details ofactuation mechanisms as well as other devices and methods that mayincorporated with the embodiments described throughout thisspecification are described in U.S. Patent Publication No. 2006-0069397A1, published Mar. 30, 2006, the entirety of which is herebyincorporated by reference.

The operation of the device 100, described above, according to oneembodiment is illustrated in sequence in FIGS. 10A-10L in conjunctionwith a procedure for closing a patent foramen ovale (PFO) in a patient'sheart. As shown in FIG. 10A, the distal end of a suturing device 100 isadvanced through a venous access, such as the inferior vena cava, intothe patient's left atrium and positioned in the tunnel 8 of the PFObetween the septum primum 7 and the septum secundum 6. The suturingdevice 100 may be advanced over a guidewire 10 or alternativelydelivered through a catheter introducer sheath 11 using techniques whichare known in the art.

The suturing device 100 is initially positioned with the distal tipextending beyond the tunnel of the PFO, such that the spreader assembly30, and thus the suture clasp deployment arms are adjacent the tip ofthe secundum primum 7. As shown in FIG. 10B, the suture clasp arms 31Aand 31B may then deployed from the spreader assembly such that theproximal suture clasp arm 31A extends around the tip of the secundumprimum 7. The suture clasp arm 31A holds a suture portion 52A extendingfrom opening 42 (FIG. 2B) on the suturing device in suture clasp 33Asuch that the suture portion is positioned on the opposite side of thesecundum primum 7 relative to the suturing device 100. The distal sutureclasp arm 31B is also extended from the spreader assembly and abuts theseptum secundum 6, causing the suturing device 100 and proximal sutureclasp arm 31A to be pushed toward the septum primum, thus assisting toproperly position the proximal suture clasp arm 31A adjacent to theseptum primum 7.

Once the suture clasp arm 31A has been properly positioned around theseptum primum 7, needle 161 may be deployed from the suturing device 100to penetrate the septum primum 7 and engage the suture clasp armpositioned on the opposite side of the septum primum 7, as shown in FIG.10C. As discussed above, the needle 161 is advanced through a passagewayin the suturing device and deflected by needle guide 60A along an anglethat intersects the deployed suture clasp arm 31A as it exits thesuturing device 100. The needle has a sharp distal tip which penetratesthe tissue of the septum primum and engages suture clasp 33A located onthe tip of the suture clasp arm 31A. The needle is initially advancedthrough the suture clasp 33A which holds a suture portion 52A. When theneedle is advanced through the suture clasp 33A, a groove on the needletip engages the suture portion 52A.

As shown in FIG. 10D, once the suture loop has been engaged, the needle161 and engaged suture portion 52A are then retracted through the tissueof the septum primum 7 and into the needle passageway of the suturingdevice 100. Once the suture has been engaged and pulled through thetissue of the septum primum, the suture clasp arms 31A and B may then beclosed and the device may be repositioned such that the spreaderassembly 30 and suture clasp arms 31A and B are adjacent the tip of theseptum secundum 6. Alternatively, the suture clasp arms may remainextended.

As shown in FIG. 10E, the suturing device is withdrawn proximallythrough the tunnel of the PFO 8 until the suture clasp arms can bedeployed such that the distal suture clasp arm 31B extends around thetip of the septum secundum 6. The suture clasp arm 31B holds a sutureportion 52B extending from opening 42 on the suturing device 100 insuture clasp 33B such that the suture portion 52 b is positioned on theopposite side of the septum secundum 6 relative to the PFO 8 and thesuturing device 100. The proximal suture clasp arm 31A is also extendedfrom the spreader assembly and abuts the septum primum 7, causing thesuturing device 100 and distal suture clasp arm 31B to be pushed towardthe septum secundum 6, thus assisting to properly position the distalsuture clasp arm 31B around the septum secundum 6.

Once the suture clasp arm 31B and suture portion 52B have been properlypositioned around the septum secundum 6, a needle 165 may be deployedfrom the distal end of the suturing device 100 to penetrate the septumsecundum 6 and engage the suture portion 52B. As shown in FIG. 10F, thetip of the needle 165 is advanced from a location distal the sutureclasp arms 31A and 31B through the tissue of the septum secundum 6towards deployed suture clasp arm 31B. As discussed above with respectto FIGS. 8A-8C, the needle 165 comprises a turned portion 166, such thatthe turned portion 166 will be advanced toward the deployed suture arm31B, as shown, when the proximal portion of the needle 165 is pulledproximally through the suturing device 100. As the turned portion of theneedle 166 is advanced from the suturing device 100, the turned portion166 is deflected outward by a needle guide 60B along an angle thatintersects the suture clasp 33B located on the tip of deployed suturearm 31B. The needle 165 has a sharp distal tip which penetrates thetissue of the septum secundum 6 and engages suture clasp 33B located onthe tip of the suture clasp arm 31B. The needle 165 is initiallyadvanced through the suture clasp 33B which holds a portion of suture 52b. When the needle 166 is advanced through the suture clasp 33B, agroove on the needle tip engages the suture portion 52 b.

As shown in FIG. 10G, once the suture portion 52B has been engaged, theneedle 165 and engaged suture portion 52B are then retracted through thetissue of the septum secundum 6 and into a cavity on the distal tip 70of the suturing device 100. Once the suture portion 52B has been engagedand pulled through the tissue of the septum secundum, the suture clasparms 31A and B may then be closed and the suturing device may bewithdrawn from the patient's heart. As shown in FIG. 10H, suture portion52A has been positioned through the septum primum 7 while suture portion52B has been positioned through the septum secundum. After the suturingdevice 100 has been withdrawn, the suture portions 52A and 52B willextend proximally from the PFO tunnel 8. These suture end portions canthen be pulled tight as shown in FIG. 10I to draw the septum secundum 6and septum primum 7 towards one another and close the PFO.

FIG. 10J shows an alternative configuration for the septum primum andthe septum secundum after the suture end portions are pulled tight toclose the PFO. In FIG. 10J, the flap of the septum secundum 6 turns orfolds so that the tips of both the septum primum and septum secundumextend in the same direction. FIG. 10K illustrates an alternativeembodiment where the flap of the septum primum turns or folds so thatthe tip of the septum primum extends in the opposite direction comparedto the tip of the septum secundum.

With the suture portions 52A and 52B extending away from the PFO, a knotmay be applied to the PFO to close the PFO. For example, a device forapplying a knot may be used, such as described in U.S. PatentPublication No. 2007-0010829 A1, published Jan. 11, 2007, the entiretyof which is hereby incorporated by reference. FIG. 10L illustratesanother embodiment in which a patch 254 may be applied and may bedelivered over the suture portions 52A and 52B to the PFO. Furtherdetails regarding delivery of a patch, as well as other devices,structures and methods that may be incorporated with the above or belowembodiments, may be found in U.S. Pat. Nos. 5,860,990, 6,117,144, and6,562,052, the entirety of each which is hereby incorporated byreference.

FIGS. 11A-11E illustrate an alternative sequence for delivering sutureto close a PFO. In FIG. 11A, the extended suture clasp arm 31B is firstpositioned around the septum secundum 6, and as shown in FIG. 11B, theneedle 165 is advanced proximally through tissue of the septum secundumto engage the suture portion 52B. The needle is withdrawn from theseptum secundum 6, carrying the suture portion 52B with it, into theelongate body. In FIG. 11C, the extended suture clasp arm 31A is thenpositioned around the septum primum 7, and as shown in FIG. 11D, theneedle 161 pierces the tissue of the septum primum to engage sutureportion 52A in suture clasp arm 31A. As shown in FIG. 11E, the needle161 is retracted, carrying the suture portion 52A into the elongatebody. The suturing device 100 can then be withdrawn from the PFO, andthe PFO can be closed as described above.

FIGS. 12A-12L illustrate another embodiment of a suturing device 100used for closing the PFO. The suturing device 100 is similar to thesuturing devices described above, except that the distal tip 70 of thesuturing device may comprise an elongated distal tip that assists innavigating the device over the guidewire 10 and through the tunnel ofthe PFO. As illustrated in FIG. 12A, the suture portions 52A, 52B mayexit the port or opening 42, with suture portion 52B extending to thedistal suture clasp arm 31B, and the suture portion 52A extending intoport 71 before returning proximally to the proximal suture clasp arm31A. The suturing device 100 may be delivered over the guidewire 10 tothe PFO as described above, and as illustrated in FIG. 12A, may bepositioned with the spreader assembly 30 located proximal to the PFOtunnel 8.

As shown in FIG. 12B, the suture clasp arms 31A and 31B may be deployedfrom the spreader assembly 30. The spreader assembly 30 may be spacedaway from the PFO prior to deployment of the suture clasp arms, to allowthe arms room to deploy. The suturing device 100 may then be advancedsuch that the distal suture clasp arm 31B engages or is positionedadjacent the septum secundum 6. The suture clasp arm 31B holds sutureportion 52B extending from opening 42 on the suturing device. As shownin FIG. 12C, needle 165 may then be deployed from the suturing device,passing through tissue of the septum secundum into engagement withsuture portion 52B carried by the suture clasp arm 31B. Retraction ofthe needle 165, as shown in FIG. 12D, carries the suture portion 52Bthrough the tissue of the septum secundum 6 and into the body of thesuturing device 100.

With the first suture portion 52B extending through tissue of the septumsecundum, the suturing device may be partially withdrawn from the tunnelof the PFO and the suture clasp arms 31A and 31B may be retracted backinto the suturing device, as shown in FIG. 12E. While in this lowprofile configuration, the suturing device can then be advanced furtherthrough the tunnel of the PFO into the left atrium, and the suture clasparms 31A and 31B can be deployed once they are positioned past thetunnel of the PFO, as shown in FIG. 12F. FIG. 12G shows the suturingdevice 100 partially retracted to cause the proximal suture clasp arm31A to engage or be positioned around or adjacent the septum primum 7.As shown in FIG. 12H, needle 161 can then be advanced from the suturingdevice, through tissue of the septum primum 7, and into engagement withthe suture portion 52A carried by the suture clasp arm 31A. Retractionof the needle 161 back into the suturing device, as shown in FIG. 12I,carries the suture portion 52A through tissue of the septum primum 7.

FIG. 12J illustrates the suturing device advanced further into the leftatrium to allow the suture clasp arms 31A and 31B room to close beforewithdrawal of the device. With the arms closed or retracted, as shown inFIG. 12K, the suturing device 100 can be withdrawn from the tunnel ofthe PFO, as shown in FIG. 12L. The PFO may be closed using the sutureportions 52A and 52B according to methods hereinbefore described.

FIG. 13 shows a suturing device 1100 for suturing an opening in a vesselwall or other biological tissue. While the device will be described inreference to suturing an opening in the heart wall, such as a patentforamen ovale (PFO), the device 1100, like the device 100, could be usedto close other openings in the heart wall, such as a patent ductusarteriosus (PDA) or an atrial septal defect (ASD), other openings inbodily tissue, or the like. The device 1100 could also be used to sutureadjacent biological structures or any other time it may be desired toapply a suture to a biological structure, or to perform other proceduresas described above with respect to the device 100.

The suturing device 1100 comprises an elongate tubular member 1020having a spreader assembly 1090, shown in greater detail in FIGS. 14Aand 19, connected to the distal end of the elongate tubular member 1020for positioning in the opening of the PFO. A handle 1200 is provided atthe proximal end of the tubular member 1020.

The elongate tubular member 1020 can be similar to the elongate tubularmember 20 in some respects. For example, as shown in more detail in FIG.15A, the elongate tubular member 1020 has a plurality of lumens 1021,1022, 1023 and 1024 extending along the axial length of the member 1020in a generally stacked arrangment. Also, the elongate tubular member1020 can have similar dimensions to the elongate tubular member 20.Additionally, the member 1020 can be manufactured by similar techniquesand from similar materials to the member 20.

The elongate tubular member 1020 can differ from the elongate tubularmember 20 in some respects. For example, in addition to the lumens 1021,1022, 1023 and 1024 arranged generally across a diameter of the elongatetubular member 1020, the elongate tubular member 1020 may additionallycomprise a one or more lumens, such as lumens 1025, 1026, and 1027 thatare shown in FIG. 15A as extending axially within elongate tubularmember 1020 on either side of the lumens 1021, 1022, 1023 and 1024.

In some embodiments, as will be discussed below in more detail, thelumens 1021, 1022, 1023, 1024, 1025, 1026 and 1027 can be used toprovide access through the elongate tubular member 1020 for a guidewire,to provide access for one or more actuating rods connected to sutureclasp arms, to house one or more suture catch mechanisms or needles, andto deliver one or more sutures to the distal end of the elongate tubularmember 1020. Some embodiments may also employ these lumens, or includefurther lumens, for injection of die, housing an additional guidewire,or to facilitate molding of the elongate tubular member.

For example, an elongate tubular member 1020′, shown in FIGS. 14B and15B, includes lumens for injection of die and an additional guidewire.The elongate tubular member 1020′ is similar to the elongate tubularmember 20 in some respects. Thus, similar features of the elongatetubular member 1020′ are indicated with numerals similar to those ofelongate tubular member 1020 followed by a prime (′). Additionally,elongate tubular member 1020′ comprises a lumen 1028′ through which diecan be injected into the treatment site, and a lumen 1029′ for a secondguidewire 1010. In additional embodiments, further lumens may be usedfor other purposes, such as for injection of die to an additionallocation or to house yet another guidewire.

The elongate tubular member 1020′ can comprise one or more openings nearthe spreader assembly 1090 between the lumen 1028′ and the treatmentsite to permit expulsion of die from the lumen 1028′. Alternatively oradditionally, die may pass from the lumen 1028′ through a spreaderassembly 1090′ to the treatment site.

Similarly, the second guidwire 1010 can pass through the lumen 1029′into the spreader assembly 1090′, which can have a guide, ramp or otherfeature to direct the second guidewire 1010 through an opening 1043′ andaway from the spreader assembly 1090′. Alternatively or additionally,the elongate tubular member 1020′ can comprise an opening proximal toand near the spreader assembly 1090′ between the lumen 1029′ and thetreatment site for passage of the second guidewire 1010.

Referring again to FIG. 14A, the spreader assembly 1090 is bonded, orotherwise joined, to the distal end of the elongated tubular member1020, for example, with epoxy or by any other suitable technique knownto those skilled in the art. The spreader assembly 1090 can comprise aspreader 1030 (FIG. 18), one or more suture clasp arms 1031, a casing1040, and a distal tip 1070.

Referring to FIGS. 16-18, the spreader 1030 comprises one or morelumens. The spreader 1030 has lumens 1133 and 1136 that extend generallyparallel to a longitudinal axis of the spreader assembly 1090, as shownin FIG. 16. When the spreader 1030 and the elongate tubular member 1020are properly connected, the lumens 1022, 1023, and 1024 of the member1020 are preferably substantially aligned with the lumen 1133 of thespreader 1030, and the lumen 1026 of the member 1020 is preferablysubstantially aligned with the lumen 1136 of the spreader 1030 toprovide continuous passageways between the elongate tubular member 1020and the spreader 1030.

In some embodiments, a casing 1040 is placed over the connection betweenthe elongate tubular member 1020 and the spreader 1030 to facilitateproper alignment of the internal lumens of the elongate tubular member1020 and spreader 1030, as shown in FIG. 18A. The casing is preferablymade of metal, but can also be made of other materials such as plastics.

As illustrated in FIG. 14A, the casing 1040 can comprise openings, orrecesses, 1041A and 1041B located on the opposite sidewalls of thecasing 1040 for allowing the release and deployment of a pair of sutureclasp arms 1031A and 1031B housed within the spreader 1030. Accordingly,the openings 1041A and 1041B are sized and shaped to permit the sutureclasp arms to fully extend from the spreader 1030.

In some embodiments, the casing 1040 has a length such that when theproximal end of the casing 1040 is positioned over the connectionbetween the spreader 1030 and the elongate tubular member 1020, thedistal end of the casing 1040 extends beyond the distal end of thespreader 1030 and, in some embodiments, engages a distal tip 1070 and/ora housing, such as housing 1080 shown in FIGS. 18A and 19, that ispositioned between the spreader 1030 and the tip 1070.

As shown in FIG. 14A, the pair of suture clasp arms 1031A and 1031B arehoused in the recesses 1041A and 1041B in the spreader assembly 1090.During storage and delivery of the suturing device, the suture clasparms 1031A and 1031B are situated substantially parallel to thelongitudinal axis of the suturing device such that the outer walls ofthe suture clasp arms do not extend beyond the outer diameter of thespreader assembly 1090.

The suture clasp arms 1031A and 1031B are connected to actuating rods1035A and 1035B which extend through the passageways formed by lumens1133 and 1136 in the spreader assembly and lumens 1024 and 1026 in theelongate tubular member 1020, as shown in FIG. 15A. After insertion andpositioning of the suturing device at the PFO or other opening, the arms1031A and 1031B can be deployed to the position shown in FIG. 19 bymovement of the actuating rods 1035A and 1035B relative to the spreader1030.

In the embodiment illustrated in FIGS. 14A and 19, the distal sutureclasp arm 1031A and the proximal suture clasp arm 1031B are manufacturedas separate components. The distal suture clasp arm 1031A and theproximal suture clasp arm 1031B are shown in greater detail in FIGS. 20and 21, respectively. Each of the arms 1031 may be pivotally connectedto the spreader 1030 at a first connection point, such as pivotapertures 1091, and connected to the actuating rods 1035 at a secondconnection point, such as apertures 1092. The arms may be connected tothe spreader 1030 and the actuating rods 1035 by pins or by othertechniques, such as by integral construction employing one or morecompliant hinges. Accordingly, movement of the actuating rods 1035relative to the spreader 1030 results in movement of the arms 1031.

When deployed, the suture clasp arms 1031A and 1031B extend from thesuturing device 1100 in opposite directions from the longitudinal axisof the device. Preferably, the arms 1031A and 1031B form an acute anglewith the longitudinal axis of the spreader. In some embodiments, a firstarm 1031A extends outward toward the proximal end of the spreaderassembly 1090 at an angle of between about 35-55°, alternatively about40-50°, alternatively about 45° with respect to the longitudinal axis ofthe spreader assembly 1090. The second arm 1031B can extend outwardtoward the distal end of the spreader assembly 1090 at approximately thesame angle as the first arm 1031A with respect to the longitudinal axisof the spreader assembly 1090. In other embodiments, the second arm1031B can extend outward from the spreader assembly 1090 at angle largeror smaller than the angle of the first arm 1031A with respect to thelongitudinal axis of the spreader assembly 1090.

As shown in FIGS. 29B and 29F, the suture clasp arms 1031A and 1031B canbe independently actuated to be individually deployed depending upon thelocation of the tissue portion to be sutured. For example, in closing aPFO, the suturing device will first be positioned with respect to afirst tissue portion to be sutured and then moved to a second positionfor suturing a second tissue portion. More specifically, as shown inFIG. 29B, when closing a PFO, the suturing device 1100 can be firstpositioned such that suture clasp arm 1031A extends around the septumprimum 7 such that suture portion 52A may be engaged and pulled thoughthe septum primum 7 to draw it toward the septum secundum 6. Thenon-engaged suture clasp arm 1031B can remain retracted in the spreader1030, as shown in FIG. 29B.

The suture clasp arms 1031A, 1031B, like the suture clasp arms 31, havesuture clasps 1033A, 1033B (see FIG. 19) for receiving and holding asuture 50. The suture clasps 1033A, 1033B of the suture clasp arms1031A, 1031B may be configured in a manner similar to or the same asthat described with respect to the suture clasps 33. For example, eachclasp 1033 can be a circular opening with a diameter sized to securelyreceive and hold a loop of suture 50.

In use, the suture ends are positioned in the suture clasps 1033A and1033B of the suture clasp arms 1031A and 1031B and held securely thereuntil they are engaged and removed by suture catch mechanisms 1161 and1165. As discussed above, the suture clasp arms 1031A and 1031B cancomprise slots 1034A and 1034B (FIGS. 20 and 21) to guide the sutureinto the suture clasps 1033 at the proper angle and assist inmaintaining the suture loops in the suture clasp until they are engagedby the suture catch mechanisms. When the suture catch mechanism engagesthe loops of the suture ends, the suture loops will slide out of thesuture clasp 1033 and be released by the suture clasp arm 1031.

In some embodiments, the suture clasp arms 1031 can comprise legs 1093that extend away from the clasps 1033, as illustrated in FIGS. 20 and21. The legs 1093 can engage tissue portions at a location remote from alocation where a suture catch mechanism is to penetrate a biologicalstructure. The legs 1093 can gather the tissue toward the location wherethe suture catch mechanism is to penetrate the biological structure tofacilitate secure suturing of the biological structure.

The suture 50 can be housed in the lumen 1025 (see FIG. 15A) of theelongate tubular member 1020. The suture lumen 1025 can have a port oropening 1042 near the distal end of the elongate tubular member 1020, asshown in FIG. 19. The suture 50 can be advanced through the opening 1042such that the suture ends, or end portions 52A and 52B, extend outsideof the suturing device 1100. One of the suture end portions 52B mayextend from the opening 1042 to the suture clasp arm 1031B. The othersuture end portion 52A may extend along the length of the casing andinto a side opening 1081 in the housing 1080 (see FIGS. 19, 24, and 26).The suture portion 52A may loop back out of the opening 1081 to thesuture clasp arm 1031A.

The housing 1080 can have one or more openings that align withcomplementary openings in the spreader 1030. For example, the housing1080 can comprise a groove, slot or lumen 1089 extends generallyparallel to a longitudinal axis of the housing 1080, as shown in FIGS.24 and 25. When the spreader 1030 and the housing 1080 are properlyconnected, the slot 1089 of the housing 1080 is preferably substantiallyaligned with a groove, slot, or lumen 1139 (see FIGS. 16-17) of thespreader 1030 to provide continuous passageways between the housing 1080and the spreader 1030. In some embodiments, the housing 1080 cancomprise an aperture 1085 that intersects the slot 1089 and extendsdistally toward a central longitudinal axis of the housing 1080, asshown in FIG. 25.

Additionally or alternatively, the housing 1080 can comprise apertures1083 and 1088, shown in FIG. 24, that extend generally parallel to alongitudinal axis of the spreader assembly 1090. When the spreader 1030and the housing 1080 are properly connected, the apertures 1083 and 1088of the housing 1080 are preferably substantially aligned with lumens1133 and 1138 (see FIG. 17) of the spreader 1030 to provide continuouspassageways between the housing 1080 and the spreader 1030.

The aperture 1088 can extend generally along the longitudinal axis ofthe housing 1080 and may extend entirely through the housing or may, asshown in FIG. 24, extend only partially through the housing 1080. Theaperture 1080 can be intersected by the side opening 1081 and an opening1082. In some embodiments, the aperture 1083 can be intersected by anaperture 1084.

In some embodiments, the housing can comprise a suture retentionmechanism. For example, referring to FIG. 26, the aperture 1088 canaccommodate a follower pin 1094 and a spring 1095 that urges thefollower pin out of the opening 1088. A cross pin 1096 can extendthrough the opening 1082 and engage the follower pin 1094 to limit therange of travel of the follower pin 1094 and inhibit rotation of thefollower pin 1094 within the aperture 1088.

A proximal end of the follower pin 1094 engages a cam leg 1097 of thearm 1031A, shown in FIG. 20 such that when the arm 1031A is in theretracted position (see FIG. 14A) the cam leg 1097 pushes the followerpin 1094 into the aperture 1088 compressing the spring 1095. As the arm1031A is extended from the spreader 1030 the cam leg 1097 moves awayfrom the housing 1080 allowing the follower pin 1094 to move proximally.

The follower pin 1094 can have a hook 1098, as illustrated in FIG. 26. Aportion of the suture 50 that is looped through the opening 1081 extendsaround the hook 1098. When the arm 1031A is moved into the closedposition, the follower pin 1094 moves distally such that the hookretains the suture 50 within the opening 1081. As the follower pin 1094moves proximally when the arm 1031A is extended from the spreader 1030,the hook 1098 releases the suture 50 to permit the suture 50 to bepulled from the opening 1081.

The suture retention mechanism can allow the user of the device 1100 tocontrol the release of the suture 50 from the opening 1081 in thehousing 1080 to reduce the likelihood of the suture end portion 52Abeing pulled prematurely from the suture clasp 1033A, to provide slackin the suture 50 when the suture catch mechanism retrieves the sutureend portion 52A, and to release the suture 50 to permit the suture catchmechanism pull the suture 50 through a biological structure.

In some embodiments, the suture catch mechanism 1161 can be similar toor the same as the suture catch mechanism 161, shown in FIG. 7A. Thesuture catch mechanism 1161 can be configured for engaging the sutureclasp arm 1031A and can comprise an elongate, straight needle.

In some embodiments, the suture catch mechanism 1165 can be similar toor the same as the suture catch mechanism 165, shown in FIG. 7B. Thesuture catch mechanism 1165 is configured to engage a suture clasp arm1031B and can comprise a bent needle.

In use, the needles 1161 and 1165, like the needles 161 and 165 shown inFIG. 8A, can be housed within passageways formed by lumens within theelongate tubular member 1020, spreader 1030, and the housing 1080.Referring to FIG. 18A, the suture catch mechanism 161 is slidably housedin the lumen 1021 of the elongate tubular member 1020, while suturecatch mechanism 165 is slidably housed in the passageway formed by thelumen 1023 of the elongate tubular member, the lumen 1133 of thespreader 1030, and lumen 1083 of the housing 1080.

As shown in FIGS. 16-18, the spreader 1030 includes a plurality ofneedle guides 1060A and 1060B for guiding a plurality of suture catchmechanisms, such as a needle or other penetrating mechanism, towards thedeployed suture clasp(s). In one embodiment, the spreader 1030 maycomprise two needle guides 1060A and 1060B located on the distal andproximal ends of the spreader 1030 for guiding two needles towarddeployed suture arms 1031A and 1031B illustrated in FIG. 19. Each of theneedle guides 1060A and 1060B comprises an angled groove or channel inthe sidewall of the spreader 1030 such that it will deflect a suturecatch mechanism, or needle, exiting the suture assembly 1090 along apath that intercepts the suture clasps 1033A and 1033B of the sutureclasp arms when the suture clasp arms 1031A and 1031B are in a deployedposition. In some embodiments, the suture arms 1031A and 1031B may besimilar to or the same as the suture arms 31A and 31B. For example, thesuture arms 1031A and 1031B can be sized such that a groove having anangle of between about 10-35°, alternatively about 15-25°, alternativelyabout 19° with respect to the longitudinal axis of the spreader assemblywill spread the needles to the proper angle to engage the suture loopsin the deployed suture clasps 1033.

In use, the proximal needle guide 1060A (FIGS. 16 and 18A) is alignedwith the lumen 1021 of the elongate tubular member such that when asuture catch mechanism is advanced through the lumen 1021, the distalend of the needle will be deflected by the needle guide 1060A towardsthe deployed suture clasp arm 1031A. Once the needle 1161 penetrates thesuture clasp 1033A on the suture clasp arm 1031A and engages the sutureportion 52A held by the suture clasp 1033A, the needle 1161 may beretracted back into the lumen 1021 with the suture portion 52A held onthe distal end of needle 1161, in a manner similar to that shown in FIG.8C.

Likewise, distal needle guide 1060B (FIGS. 17 and 18A) is aligned withaperture 1083 of the housing 1080 such that when the distal tip of aneedle housed in aperture 1083 is extended towards the suture clasp arm1031B, the needle will be deflected toward the suture clasp 1033B.Before insertion, the needle 1165, similar to the needle 165, has beenadvanced through the lumen 1023 in the elongate tubular member 1020beyond the spreader 1030 and positioned a slot or cavity 1083 within thehousing 1080 of the suturing device that has been aligned with the lumen1133 of the spreader 1030. The cavity 1083 is sized to receive thedistal end of the needle 1165, including a turned portion similar to theturned portion 166 (see FIG. 7B). The turned portion is positioned incavity 1083 such that the distal tip is aligned with the needle guide1060B located on the distal end of the spreader 1030.

Thus, in use, when the proximal end of the needle 1165 is pulled backthrough the lumen 1023 of the elongate tubular member 1020, the turnedportion of the needle will be advanced along the groove of the needleguide 1060B and deflected outward along the angle path of the groove topenetrate the deployed suture clasp 1033B on the suture clasp arm 1031Band engage suture portion 52B held therein. Once the needle 165 hasengaged the suture portion 52B, the proximal end of the needle 165 maythen be pushed forward through the lumen 1023 of the elongate tubularmember which will cause the bent portion of the needle to be retractedalong needle guide 1060B into cavity 1083 along with the suture portion52B held on the needle 1165.

Under some circumstances, a suture catch mechanism, such as the needle1161 or the needle 1165, when advanced may be oriented in directiontoward a location slightly closer to or slightly farther from alongitudinal axis of the device 1100 than the center of the suture clasp1033. A suture catch mechanism that is oriented in a direction that istoward a location slightly closer to or slightly farther from thelongitudinal axis of the device 1100 than the center of the suture clasp1033 may, in some instances, not properly engage the suture. As aresult, the suture catch mechanism may not successfully retract thesuture end portion.

In some embodiments, the one or more of the suture clasp arms 1031 canhave a deflector, such as deflecting plates 1099, 2099, shown in FIGS.20-23. The deflecting plates 1099, 2099 are shown partially obscuring anopening on a back side of the suture clasp 1033 relative to thedirection from which a suture catch mechanism, such as a needle 2161,penetrates the suture clasp 2033, as shown in FIG. 22. As the needle2161 passes through the suture clasp 2033, the needle 2161 engages thedeflector plate 2099, as shown in FIG. 22, and is diverted from itsprevious course toward a longitudinal axis of the device 1100. In analternative embodiment, the suture catch mechanism can be diverted awayfrom a longitudinal axis of the device. As the needle 2161 is divertedtoward the longitudinal axis of the device, a suture engaging portion,such as a hook, recess, or groove 2161, moves toward a portion of asuture end 2052, shown schematically in FIG. 22.

The dimensions of the needle including the size and location of thesuture engaging portion and the size and shape the needle tip, the sizeof the suture clasp, and the distance by which the deflectors obscurethe back opening of the suture clasp should be relatively proportionedsuch that the deflectors 1099, 2099 cause the suture engaging portion ofthe needle to engage the portion of the suture end as the needle returnsto its previous orientation. Thus, in the embodiment illustrated in FIG.22, the hook 2162 would engage the suture portion 2052 as it retractedfrom the suture clasp 2033.

The deflector plates may be generally rectangular, as shown in FIG. 23,or may have other configurations, such as generally H-shaped as shown inFIG. 21. In some embodiments, the deflector plates can be made frommetal, while in other embodiments the deflector plates can be made ofplastics or other materials of sufficient rigid or resiliency to deflecta suture catch mechanism. The deflector plates may be joined to thesuture clasp arms by welding, epoxy, adhesives or by other methods. Inan alternative embodiment, the deflectors can be integrally formed withthe suture clasp arm.

In some embodiments, the deflectors can compensate for misalignment of asuture catch mechanism with the center of a suture clasp relative to alongitudinal axis of the device to provide consistent capture of asuture end portion by the suture catch mechanism.

In some embodiments, bending of the elongate tubular member can affectthe relative positions of the ends of the suture catch mechanisms to thespreader assembly. For example, if an elongate tubular member is bentthen a distal end of a suture catch mechanism extending along the insideof the bend in the elongate member relative to the central axis of theelongate tubular member would be advanced relative to the spreaderassembly. In such a circumstance, the suture catch mechanism may beadvanced through a suture clasp farther than is desired, which mayresult in enlargement of a loop at an end of a suture that in turninhibits the ability of the suture catch mechanism to retract the and ofthe suture.

On the other hand, if an elongate tubular member is bent then a distalend of a suture catch mechanism extending along the outside of the bendin the elongate member relative to the central axis of the elongatetubular member would be retracted relative to the spreader assembly. Insuch a circumstance, the suture catch mechanism may not be advancedthrough a suture clasp far enough to engage a suture end portion held bythe suture clasp.

In some embodiments, the effects of bending of the elongate tubularmember can be reduced or eliminated by using a suture catch mechanismthat is sufficiently long to engage the corresponding suture clasp evenif the suture catch mechanism extends along the outside of a bend in theelongate member relative to the central axis of the elongate member.Advancement of the suture catch mechanism may be limited by providing astop mechanism in proximity to the spreader assembly where the effectsof bending are small or absent.

For example, as illustrated in FIG. 18B, a tube 1061 can be attached tothe needle 1161 and another tube 1062 can be attached to the elongatetubular member 1020 within a counterbore in the lumen 1021. The innerdiameter of tube 1062 is smaller than the outer diameter of tube 1061such that tube 1061 cannot be advanced through tube 1062, therebylimiting the advancement of the needle 1161 relative to the spreader1030.

Alternatively, the tube 1061 can be attached to the needle 1161 andextend over a portion of the length of the needle 1161 within the lumen1021. In this configuration, the tube 1061 limits the movement of thesuture catch mechanism by preventing movement of the suture catchmechanism along the guide 1060A by interference of the tube 1061 withthe proximal end of the spreader 1030.

Similarly, movement of the bent needle 1165 toward the suture clasp arm1031B can be limited by attachment of a tube 1065 to the needle 1165 ata location distal to the spreader 1030. The tube 1065 has an outerdiameter that is larger than a dimension of the lumen 1133 such that thetube 1065 cannot be moved into the spreader 1030 as the needle 1165 ismoved proximally, thereby limiting the movement of the needle 1161relative to the spreader 1030 in a proximal direction.

In an alternative embodiment, the suture catch assembly may comprisefour needles, for example two needles housed on each side of theelongate tubular member for engaging multiple suture portions in each ofthe suture clasp arms. Here, each of the needles may be independentlyactuated or alternatively both needles for engaging a single sutureclasp arm may be jointly actuated such that they are deployed at thesame time.

The distal tip 1070 is shown in FIGS. 14A, 19, and 29A as having atapered configuration, but may alternatively be rounded or have otherconfigurations. The distal tip 1070 is preferably atraumatic and can bebonded, adhered, or otherwise joined to the distal end of the spreaderassembly 1090, for example, by insert molding or any other suitabletechnique known to those skilled in the art. The distal tip 1070 canhave at least one lumen 1072 that forms a continuous passage with theaperture 1085 and the slot 1089 of the housing 1080 (FIG. 25) and theslot 1039 (FIG. 16) of the spreader 1030 and lumen 1027 of the elongatetubular member 1020 (FIG. 15A), which may accommodate, for example, aguidewire.

In addition, the distal tip 1070 may have one or more additional lumens1173 that can be aligned with lumens in the spreader assembly 1030 andelongate tubular member 1020 to provide additional continuouspassageways, for example for housing a suture catch mechanism. Here, asdiscussed above, the outer diameter of the distal tip is substantiallythe same size as the inner diameter of the casing 1040 such that whenthe distal end of the casing 1040 is positioned over the connectionbetween the distal tip 1070, the housing 1080, and the spreader 1030,the casing maintains the proper alignment of the internal lumens of thedistal tip 1070, the housing 1080, the spreader 1030, and the elongatemember 1020.

Referring now to FIGS. 27, 28A, and 28B, the proximal end of the needles1161 and 1165 extend through the lumens 1021 and 1023 of the elongatetubular member and terminate at a connection to pulls 1210 and 1216 onthe suturing device handle 1200. The handle 1200 includes a housing 1201which is attached to the proximal end of the elongate tubular member1020. The housing 1201 has an aperture 1202 providing a passagewaybetween the handle 1200 and the multiple lumens of the elongate tubularmember 1020. One or more actuators 1210, 1216, 1240 and 1260 may extendfrom the housing 1201. The pulls or knobs 1210, 1216, 1240 and 1260 canbe connected to actuating rods or mechanisms for deploying and/orretracting the suture clasp arms and suture catch mechanisms moveablyhoused in the suturing device.

The elongate member 1020 is fixed to the housing 1201 in any suitablemanner such as by welding, adhesion, or other bonding process to acollar 1203. The cylinder 1203 is engaged by the housing 1201. Thecylinder 1203 can be rectangular or any other shape. The cylinder 1203is connected to the housing 1201 in a manner that prevents limitsrotation of the cylinder 1203 with the member 1020 relative to thehousing 1201. The elongate member 1020 has a plurality of cutouts (notshown) that expose the actuator rods 1035 and the suture catchmechanisms 1161 and 1165 for connection to the actuators 1210, 1216,1240, and 1260.

With reference to FIGS. 27, 28A, and 28B, in some embodiments, thehandle 1200 can have two pulls 1210 and 1216 for deploying andretracting the suture catch mechanisms such as needles 1161 and 1165 ofthe suturing device. The pulls 1210 and 1216 can extend from the housingthrough openings 1213 and 1217, respectively, as shown in FIG. 27.

In one embodiment, the proximal end of needle 1165 extends from theproximal end of the lumen 1023 in the elongate tubular member throughopening 1202 into the handle 1200 and is exposed by a cutout in theelongate tubular member 1020 for connection to a shaft 1276, shown inFIGS. 28A and 28B. The shaft 1276 can be generally U-shaped to permitthe shaft to pass over the elongate member 1020 in a direction transfersto a longitudinal axis of the member 1020. The needle 1165 may beconnected to the shaft 1276 directly by a suitable bonding process, orindirectly, such by connection to a small tube that is adhered to theneedle 1165, for example, by epoxy, which is in turn connected to a tab1286. The tab 1286 can be connected to the shaft 1276 at a notch 1296 inthe shaft 1276. The pull 1216 can be connected to the shaft by a bondingprocess or by mechanical means, such as a set screw.

Similarly the proximal end of needle 1161 extends from the proximal endof the lumen 1021 in the elongate tubular member 1020 through opening1202 into the handle 1200 and is exposed by a cutout in the elongatetubular member 1020 for connection to a shaft 1270, shown in FIGS. 28Aand 28B. The shaft 1270 can be generally U-shaped to permit the shaft topass over the elongate member 1020 in a direction transfers to alongitudinal axis of the member 1020. The needle 1161 may be connectedto the shaft 1270 directly by a suitable bonding process, or indirectly,such as by connection to a small tube (not shown) that is adhered to theneedle 1161, for example, by epoxy, which is in turn connected to a tab1280. The tab 1280 can be connected to the shaft 1270 at a notch 1290 inthe shaft 1270. The pull 1210 can be connected to the shaft by a bondingprocess or by mechanical means, such as a set screw.

In some embodiments, a spring 1218 can be positioned between the pulls1210 and 1216. The spring 1218 can bias the needle 1161 proximally andthe needle 1165 distally by biasing the pull 1210, which is connected tothe needle 1161, from the pull 1216, which is connected to the needle1165. A user can advance the needle 1161 by moving the pull 1210 tocompress the spring 1218. The spring 1218 can assist in retraction ofthe needle 1161 as the spring 1218 decompresses. Similarly, a user candraw the needle 1165 proximally by moving the pull 1216 to compress thespring 1218. As the spring 1218 decompresses the needle 1165 is moveddistally within the elongate member 1020.

The suture claps arms 1031A and 1031B can be deployed by rotation ofactuators, or knobs, 1240 and 1260. For example, the knobs 1240, 1260can be connected to threaded members 1242, 1262 in a manner thatprevents the knobs 1240, 1260 from rotating with respect to the threadedmembers 1242, 1262. A tube 1222, which can be fixedly attached to thehousing 1201, can extend through the threaded members 1242, 1262 suchthat the threaded members 1242, 1262 can both slide over and rotate withrespect to the tube 1222.

The tube 1222 can have two slots 1243 and 1263 corresponding to thethreaded members 1242, 1262. The two slots 1243 and 1263 are configuredto allow two pins 1244 and 1264 to extend through the slots 1243, 1263and operatively engage the threaded members 1242, 1262 such thatrotation of the threaded members 1242, 1262 with respect to the tube1222 causes the pins 1244, 1264 to move along the length of the slots1243, 1263.

The pins 1244, 1264 are connected to shafts 1245, 1265 positioned withinthe tube 1222. The shafts 1245, 1265 can be connected to the actuatorrods 1035A and 1035B by tabs, 1246, 1266. The tabs 1246, 1266 can bewelded or otherwise attached to the actuator rods 1035A and 1035B andattached by any suitable bonding process to the shafts 1245, 1265 atnotches 1247, 1267.

Accordingly, as a user rotates knobs 1240, 1260, the threaded members1242, 1264 move the pins 1244, 1264 along the slots 1243, 1263. Movementof the pins 1244, 1264 in a direction along a longitudinal axis of thehandle 1200 causes the shafts 1245, 1265 to move the actuator rods 1035Aand 1035B either proximally or distally depending on the direction ofrotation of the knobs 1240, 1260. As discussed above, proximal anddistal movement of the actuator rods 1035A and 1035B causes the sutureclasp arms 1031A and 1031B to move between a retracted position, shownin FIG. 14A, and an extended position, shown in FIG. 19. The knobs 1240,1260 can be rotated individually to independently deploy and retract thesuture clasp arms 1035A and 1035B.

In some embodiments, the handle 1200 can also comprise springs 1248,1268 that bias the threaded members 1242, 1262 along the tube 1222. Thesprings 1248, 1268 can bias the threaded members 1242, 1262 eitherproximally or distally. In one embodiment, the springs 1248, 1268 biasthe threaded members 1242, 1262 in directions that bias the suture clasparms 1031A, 1031B toward in their extended positions such that rotationof the threaded member 1242, 1246 past the fully open position of thesuture clasp arms 1031A, 1031B results in compression of the springs1248, 1268. Alternatively, the springs 1248, 1268 can bias the threadedmembers 1242, 1262 in directions that bias the suture clasp arms 1031A,1031B toward in their retracted positions.

The operation of the device 1100, described above, is illustratedaccording to one embodiment in FIGS. 29A-291 in conjunction with aprocedure for closing a patent foramen ovale (PFO) in a patient's heart.As shown in FIG. 29A, the distal end of a suturing device 1100 isadvanced through a venous access, such as the inferior vena cava, intothe patient's left atrium and positioned in the tunnel 8 of the PFObetween the septum primum 7 and the septum secundum 6. The suturingdevice 1100 may be advanced over a guidewire 10 or alternativelydelivered through a catheter introducer sheath 1011 using techniqueswhich are known in the art.

The suturing device 1100 is initially positioned with the distal tip1070 extending beyond the tunnel of the PFO, such that the spreaderassembly 1090 is near the tip of the secundum primum 7 and at least thesuture clasp deployment arm 1031A is permitted to extend from thespreader assembly 1090. The suture clasp arm 1031A may then deployedfrom the spreader assembly 1090 and then the device 1100 is retracteduntil the suture clasp arm 1031A extends around the tip of the secundumprimum 7, as shown in FIG. 29B, and gathers the tissue of the septumprimum 7 between the arm 1031A and the spreader 1030. Referring to FIG.26, as the arm 1031A is extended, the follower pin 1094 moves proximallyto permit the suture 50 to be pulled from the opening 1081 in thehousing 1080. With continued reference to FIG. 29B, the suture clasp arm1031A holds a suture portion 52A, which may or may not still extend fromopening 1081 of the housing 1080, in the suture clasp 1033A such thatthe suture portion 52A is positioned on the opposite side of thesecundum primum 7 relative to the suturing device 1100.

Once the suture clasp arm 1031A has been properly positioned around theseptum primum 7, needle 1161 may be deployed from the suturing device1100 to penetrate the septum primum 7 and engage the suture clasp armpositioned on the opposite side of the septum primum 7. As discussedabove, the needle 1161 is advanced through a passageway in the suturingdevice and deflected by needle guide 1060A (FIG. 18A) along an anglethat intersects the deployed suture clasp arm 1031A as it exits thesuturing device 1100. The needle has a sharp distal tip which penetratesthe tissue of the septum primum 7 and engages suture clasp 1033A locatedon the tip of the suture clasp arm 1031A, as shown in FIG. 29C. Theneedle is initially advanced through the suture clasp 1033A which holdsa suture portion 52A. When the needle is advanced through the sutureclasp 1033A, a groove or hook on the needle tip engages the sutureportion 52A.

As shown in FIG. 29D, once the suture loop has been engaged, the needle1161 and engaged suture portion 52A are then retracted through thetissue of the septum primum 7 and into the lumen 1021 of the elongatemember 1020 of the suturing device 1100. Once the suture has beenengaged and pulled through the tissue of the septum primum 7, the device1100 may be advanced slightly so that the suture clasp arm 1031A can beclosed without pinching the septum primum 7. The device 1100 may then berepositioned such that the spreader assembly 1090 is adjacent the tip ofthe septum secundum 6.

As shown in FIG. 29E, the suturing device 1100 is withdrawn proximallythrough the tunnel of the PFO 8 until the suture clasp arm 1031B can bedeployed. The suture clasp arm 1031B can then be extended then thedevice 1100 can be advanced such that the suture clasp arm 1031B extendsaround the tip of the septum secundum 6, as shown in FIG. 29F, andgathers the tissue of the septum secundum 6 between the arm 1031B andthe spreader 1030. The suture clasp arm 1031B holds a suture portion 52Bextending from opening 1042 in suture clasp 1033B such that the sutureportion 52B is positioned on the opposite side of the septum secundum 6relative to the PFO 8 and the suturing device 1100.

Once the suture clasp arm 1031B and suture portion 52B have beenproperly positioned around the septum secundum 6, the needle 1165 may bedeployed from the distal end of the suturing device 1100 to penetratethe septum secundum 6 and engage the suture portion 52B. As shown inFIG. 29G, the tip of the needle 1165 is pulled proximally from alocation distal the suture clasp arm 1031B through the tissue of theseptum secundum 6 towards deployed suture clasp arm 1031B.

The needle 1165 is deflected outward by a needle guide 1060B (FIG. 18A)as the needle 1165 extends from the suturing device 1100 along an anglethat intersects the suture clasp 1033B located on the tip of deployedsuture arm 1031B. The needle 1165 has a sharp distal tip whichpenetrates the tissue of the septum secundum 6 and engages suture clasp1033B located on the tip of the suture clasp arm 1031B. The needle 1165is initially advanced through the suture clasp 1033B which holds aportion of suture 52B. When the needle 166 is advanced through thesuture clasp 1033B, a groove or hook on the needle tip engages thesuture portion 52B.

As shown in FIG. 29H, once the suture portion 52B has been engaged, theneedle 1165 and engaged suture portion 52B are then retracted distallythrough the tissue of the septum secundum 6 and into the cavity 1083 ofthe suturing device 1100. The suture clasp arm 1031B may then be closedand the suturing device 1100 may be withdrawn from the patient's heart.

As shown in FIG. 29I, the suture portion 52A has been positioned throughthe septum primum 7 while suture portion 52B has been positioned throughthe septum secundum. After the suturing device 1100 has been withdrawn,the suture portions 52A and 52B will extend proximally from the PFO andcan then be pulled to draw the septum secundum 6 and septum primum 7towards one another to close the PFO, as shown in FIG. 10I, 10J, or 10K.As the suture 50 is pulled tight, the suture 50 preferably causes theseptum secundum 6 and septum primum 7 to turns or folds so that the tipof the septum primum 7 extends in the opposite direction compared to thetip of the septum secundum 6, as illustrated in FIG. 10 k.

With the suture portions 52A and 52B extending away from the PFO, a knotmay be applied to the PFO to close the PFO. For example, a device forapplying a knot may be used, such as described in U.S. PatentPublication No. 2007-0010829 A1, published Jan. 11, 2007, the entiretyof which is hereby incorporated by reference. Alternatively, the methodof securing the suture portions illustrated in FIG. 10L by applying apatch 254 may be used. As noted above, further details regardingdelivery of a patch, as well as other devices, structures and methodsthat may be incorporated with the above or below embodiments, may befound in U.S. Pat. Nos. 5,860,990, 6,117,144, and 6,562,052, theentirety of each which is hereby incorporated by reference.

The operation of the device 1100′, described above and shown in FIGS.14B and 15B, is illustrated according to one embodiment in FIGS. 29J-29Min conjunction with a procedure for closing a patent foramen ovale (PFO)in a patient's heart. The operation of the device 1100′ can be similarto the operation of the device 1100 in some respects. For example, thedistal end of a suturing device 1100′ is advanced through a venousaccess, such as the inferior vena cava, into the patient's left atriumand positioned in the tunnel 8 of the PFO between the septum primum 7and the septum secundum 6 then operated in the manner described abovewith reference to FIGS. 29A-D to pass a suture portion 52A through theseptum primum 7.

The operation of the device 1100′ can differ from the operation of thedevice 1100 in other respects. In particular, the device 1100′ can beused in conjunction with the second guidewire 1010 to facilitateplacement of a suture portion through the septum secundum 6 in alocation at or near a center of the septum secundum 6. Such placement ofthe suture through the septum secundum 6 may improve the likelihood ofsuccessful closure of the PFO. If the suture is placed through theseptum secundum 6 at a location too far removed from the center of theseptum secundum 6, to one side or the other, blood may continue to flowthrough the PFO after placement of the suture and application of a knotto the suture. Thus, use of the device 1100′ with the second guidewire1010 can improve the likelihood of securely closing the PFO.

Once the suturing device 1100′ has been operated in the manner describedabove with reference to FIGS. 29A-D, the suturing device 1100′ may bewithdrawn proximally through the tunnel of the PFO 8 until the sutureclasp arm 1031B′ can be deployed, as shown in FIG. 29J. The secondguidewire 1010 can be advanced from the lumen 1029′ (FIG. 15B) throughthe opening 1043′ (FIG. 14B) into the superior vena cava (FIG. 1). Thesecond guidewire 1010 may be preloaded in the device 1100′ beforeintroduction of the device 1100′ into the body such that a distal end ofthe second guidewire is near the opening 1043′.

The suture clasp arm 1031B′ can then be extended and the device 1100′can be advanced such that the suture clasp arm 1031B′ extends around thetip of the septum secundum 6, as shown in FIG. 29K, and gathers thetissue of the septum secundum 6 between the arm 1031B′ and the spreader1030′. Alternatively, the suture clasp arm 1031B′ can be extended fromthe spreader assembly 1090′ before the second guidewire 1010 is advancedinto the superior vena cava. The suturing device 1100′ can be configuredsuch that when the second guidewire 1010 is advanced into the superiorvena cava, the second guidewire 1010 directs the device 1100′ toward thecenter of the septum segundum 6 as the device 1100′ is advanced.

With the suturing device 1100′ positioned with the suture clasp arm1031B′ extending around the tip of the septum secundum 6, as illustratedin FIG. 29K, the suture clasp arm 1031B′ holds a suture portion 52Bextending from opening 1042′ in suture clasp 1033B′ such that the sutureportion 52B is positioned on the opposite side of the septum secundum 6relative to the PFO 8 and the suturing device 1100′.

Once the suture clasp arm 1031B′ and suture portion 52B have beenproperly positioned around the septum secundum 6, the needle 1165′ maybe deployed from the distal end of the suturing device 1100′ topenetrate the septum secundum 6 and engage the suture portion 52B. Asshown in FIG. 29L, the tip of the needle 1165′ is pulled proximally froma location distal the suture clasp arm 1031B′ through the tissue of theseptum secundum 6 towards deployed suture clasp arm 1031B′ to engage thesuture portion 52B.

Once the suture portion 52B has been engaged, the needle 1165′ andengaged suture portion 52B are then retracted distally through thetissue of the septum secundum 6 and into the cavity 1083′ of thesuturing device 1100′, as illustrated in FIG. 29M. The suture clasp arm1031B′ may then be closed and thereafter the second guidewire 1010retracted into the suturing device 1100′. Alternatively, the secondguidewire 1010 can be retracted into the suturing device 1100′ beforethe suture clasp arm 1031B′ is closed. Once the suture clasp arm 1031B′is closed, the suturing device 1100′ may be withdrawn from the patient'sheart and the PFO can be closed as described above.

An embodiment of a device 2100 for applying a knot to a suture,comprising a handle 2110 and an elongate tubular member 2120, isillustrated in FIGS. 30-32, which is similar in some respects to thedevices described in U.S. Patent Publication No. 2007-0010829 A1,published Jan. 11, 2007, but differs in some respects. The device 2100can be used to apply a knot to a suture in any of the methods describedabove.

The handle 2110 of the device 2100 comprises a housing 2130, a button2140, and a knob 2150. Referring to FIG. 31, the housing 2130 comprisesan aperture 2132 configured to allow longitudinal and rotationalmovement of the knob 2150, a passage 2134 for movement of the button2140 into and out of the housing 2130, and a mounting recess 2136.

The mounting recess 2136 can accommodate, support, and limit themmovement of a mounting hub 2160. The mounting hub 2160 can be fixedlyattached to the elongate member 2120. An actuating rod 2180 can extendthrough the elongate member 2120 to a shaft 2152 that is connected tothe knob 2150. The shaft 2152 can be fixedly attached to the actuatingrod 2180.

The button 2140 can comprise a pin 2142. When the button 2140 ispositioned within the passage 2134, the pin 2142 can extends into arecess 2135 of the passage 2134. The recess 2135 can be dimensioned suchthat rotation and translation of the pin 2142 and button 2140 within thepassage 2134 is constrained such that the button 2140 is not forced outof the passage 2134 by a spring 2144 that is positioned in the passage2134 between the button 2140 and the housing 2130. In some embodiments,the button 2140 can have a hook, or projection, 2146 to engage the shaft2152.

The aperture 2132 in the housing 2130 is configured to allow a user tomanipulate at least a portion of the knob 2150 and can extend along thelongitudinal axis of the device 2100 into the passage 2134. Within theaperture 2132, the housing 2130 can have a neck or ring 2138 thatslidably and rotatably supports the shaft 2152. A spring 2137 biases theknob 2150 distally from the neck 2138.

In some embodiments, the aperture 2132 can have a narrow region 2133 anda wide region 2135. The narrow region 2133 can be dimensioned to inhibitrotation of the shaft 2152 when a pin 2154, which extends from the shaft2152, is located within the narrow region 2133. As the shaft 2152 movesproximally within the aperture 2132, the pin 2154 moves from the narrowregion 2133, in which rotation of the pin 2154 is limited, into the wideregion 2135, which is large enough to allow the pin 2154 to rotate withthe shaft 2152.

The shaft 2152 can also include a recess or groove 2156 for operativeengagement with the hook 2146 of the button 2140 to retain the shaft2152 in a proximally retracted position relative to the handle 2130.When the button 2140 is advanced into the housing 2130, the hook 2146releases from the recess 2156 of the shaft 2152 and the spring 2138biases the shaft 2152 distally within the handle 2130, which in turnadvances the actuator rod 2180 distally.

As the shaft 2152 advances distally, the pin 2154 moves within theaperture 2132. Once the pin 2154 advances from the narrow region 2133into the wide region 2135, the knob 2150 can be rotated.

FIG. 32 illustrates the distal end of the elongate tubular member 2120,the actuator rod 2180, a tip 2184, and a sleeve 2190. A suture (notshown) can extend through an opening 2122 in the elongate member 2120,an opening 2192 in the sleeve 2190, and out of an opening 2124 in thedistal end of the elongate member 2120.

The sleeve 2190 can support a knot body (not shown) and a plug (notshown) of the type disclosed in U.S. Patent Publication No. 2007-0010829A1 with the suture (not shown) extending between the knot body (notshown) and the plug (not shown). As the actuator rod 2180 advances, theplug is forced into the knot body by the tip 2184 to secure the suture(not shown) between the knot body and plug in the manner described inU.S. Patent Publication No. 2007-0010829 A1.

After the suture has been secured between the knot body and the plug,the actuator rod 2180 can be rotated by the user by rotating the knob2150. While the actuator rod 2180 is in the advanced position, rotationof the rod 2180 can cause a cutting edge 2182 of the tip 2184 to rotatetoward the opening 2192 in the sleeve 2190. The opening 2192 can have acutting edge 2194 that cooperates with the cutting edge 2182 of theactuator rod 2180 to cut the suture.

FIGS. 33, 34A, 34B and 35 illustrate one embodiment of a handle 2200that can be used in conjunction with a suturing device. For example, thehandle 2200 can be connected to the elongate tubular member 1020 andspreader assembly 1090, shown in FIGS. 14A and 15A, or the elongatetubular member 1020′ and spreader assembly 1090′, shown in FIGS. 14B and15B. While the handle 2200 will be described in reference to suturingdevices, the handle 2200 could be used in conjunction with devices forother purposes.

As discussed above, in some embodiments, bending of the elongate tubularmember can affect the relative positions of the ends of the suture catchmechanisms and the spreader assembly. For example, if an elongatetubular member is bent then a distal end of a suture catch mechanismextending along the inside of the bend in the elongate member relativeto the central axis of the elongate tubular member would be advancedrelative to the spreader assembly. In such a circumstance, the suturecatch mechanism may be advanced through a suture clasp farther than isdesired, which may result in enlargement of a loop at an end of a suturethat in turn inhibits the ability of the suture catch mechanism toretract the and of the suture.

On the other hand, if an elongate tubular member is bent then a distalend of a suture catch mechanism extending along the outside of the bendin the elongate member relative to the central axis of the elongatetubular member would be retracted relative to the spreader assembly. Insuch a circumstance, the suture catch mechanism may not be advancedthrough a suture clasp far enough to engage a suture end portion held bythe suture clasp.

As discussed above, in some embodiments, the effects of bending of theelongate tubular member can be reduced or eliminated by using a suturecatch mechanism that is sufficiently long, providing a stop mechanism,or both. Additionally or alternatively, the handle 2200 can reduce oreliminate the effects of bending of the elongate tubular member.

The handle 2200 can have a housing 2201, and one or more actuators 2210,2216, 2240, and 2260 that extend from the housing 2201, as illustratedin FIGS. 33 and 34A. One or more pulls 2210 and 2216 can be actuated todeploy and retract the suture catch mechanisms, such as, needles 1161,1165 of the suturing device. One or more switches 2240, 2260 can beactuated to deploy and retract the suture claps arms 1031A and 1031B.

With reference to FIG. 33, the housing 2201 can be attached to theproximal end of the elongate tubular member 1020. The housing 2201 canhave an aperture 2202 providing a passageway between the handle 2200 andthe multiple lumens of the elongate tubular member 1020.

In some embodiments, the handle 2200 can comprise one or more ports 2205located distal to the housing 2201. The ports 2205 can comprise lumensconfigured to provide access to one or more lumens of the elongatetubular member 1020 for one or more of sutures, guidewires, or die.

Referring to FIG. 34A, the elongate member 1020 is fixed to the housing2201 in any suitable manner such as by welding, adhesion, or otherbonding process to a collar or cylinder 2203. The cylinder 2203 isengaged by the housing 2201. The cylinder 2203 can be rectangular or anyother shape. The cylinder 2203 is connected to the housing 2201 in amanner that prevents limits rotation of the cylinder 2203 with themember 1020 relative to the housing 2201.

The elongate member 1020 has a plurality of cutouts (not shown) thatexpose the actuator rods 1035 and the suture catch mechanisms 1161 and1165 to permit connection to the actuators 2210, 2216, 2240, and 2260.Referring to FIG. 15A, the proximal ends of the needles 1161 and 1165extend through the lumens 1021 and 1023 of the elongate tubular memberand terminate at a connection to pulls 2210 and 2216 on the suturingdevice handle 2200.

In one embodiment, the needles 1161, 1165 are connected to shafts, 2270,2276, respectively. The proximal ends of needles 1161, 1165 can extendfrom the proximal end of the lumens 1021, 1023, respectively, in theelongate tubular member 1020 through opening 2202 into the handle 2200(FIG. 33). The needles 1161, 1165 can be exposed by cutouts in theelongate tubular member 1020 for connection to the shafts, 2270, 2276,respectively. Referring to FIGS. 34A and 34B, the shafts 2270, 2276 caneach have a passage to permit the elongate member 1020 to pass throughthe shafts 2270, 2276. The needles 1161, 1165 can be connected to theshafts 2270, 2276 directly by a suitable bonding process, or indirectly,such as by connection to small tubes that are adhered to the needles1161, 1165, for example, by epoxy, which are in turn connected to tabs2280, 2286. The tabs 2280, 2286 can be connected to the shafts 2270,2276, respectively, at notches 2290, 2296 in the shafts 2270, 2276.

The shafts 2270, 2276 can be moved by the pulls 2210, 2216 incooperation with springs 2228, 2238. The pulls 2210, 2216 can extendfrom the housing through openings 2213 and 2217, respectively, as shownin FIG. 33. Referring to FIG. 34A, the pulls 2210, 2216 can eachcomprise an external portion 2220, 2226 and an internal portion 2230,2236, which can be integrally formed or can be connected by any bondingprocess. The external portions 2220, 2226 can be engaged by a user tomove the pulls 2210, 2216, respectively.

The internal portions 2230, 2236 of the pulls 2210, 2216 can each have apassage 2204, 2206, a first end portion 2221, 2231, and a second endportion 2223, 2233. The passages 2204, 2206 can be configured to allowthe shafts 2270, 2276 to move therein and the elongate tubular member1020 to extend through the pulls 2210, 2216. The first end portions2221, 2231 and second end portions 2223, 2233 can limit the movement ofthe shafts 2270, 2276 within the passage.

The first end portions 2221, 2231 and second end portions 2223, 2233 canbe integrally formed with the internal portions 2230, 2236, or can beseparate components. For example, in the embodiment of FIGS. 34A and34B, the first end portions 2221, 2231 are integrally formed with theinternal portions and second end portions 2223, 2233 are illustrated asseparate components which can be mechanically connected, such as bythreads, or can be connected by adhesive, or other bonding process tothe internal portions.

The springs 2228, 2238 can be positioned between the second end portions2223, 2233 and the shafts 2270, 2276, thereby biasing the shafts 2270,2276 toward the first end portions 2221, 2231. In some embodiments,collars 2227, 2237 can be positioned between the springs 2228, 2238 andthe shafts 2270, 2276. The collars 2227, 2237 may slidably move over theelongate tubular member 1020 and provide an interface between thesprings 2228, 2238 and the shafts 2270, 2276. In some embodiments, aspring 2218 can be positioned between the pulls 2210 and 2216. Thespring 2218 can bias the needle 1161 proximally and the needle 1165distally by biasing the pull 2210, which is connected to the needle1161, from the pull 2216, which is connected to the needle 1165.

In the embodiment illustrated in FIGS. 34A and 34B, a user can advancethe needle 1161 by moving the pull 2210 to compress the spring 2218. Asthe pull 2210 is advanced distally, the second end portion 2223 pushesagainst the spring 2228, which in turn pushes the shaft 2270 distallyalong with the needle 1161. However, distal advancement of the shaft2270 is limited by the first end portion 2221. Thus, a user is able toadvance the needle 1161 at a controlled rate and is able to retract theneedle 1161 by moving the pull 2210 proximally.

On the other hand, should the needle 1161 encounter resistance as thepull 2210 is advanced, such as from a stop mechanism, described above,the shaft 2270 will move away from the first end portion 2221 toward thesecond end 2223. Thus, the internal spring 2228 is compressed to avoidover-extension of the needle 1161.

Likewise, with continued reference to FIGS. 34A and 34B, a user can drawthe needle 1165 proximally by moving the pull 2216 to compress thespring 2218. As the pull 2216 is drawn proximally, the second endportion 2233 pushes against the spring 2238, which in turn pushes theshaft 2276 proximally along with the needle 1165. However, proximalmovement of the shaft 2276 is limited by the first end portion 2231.Thus, a user is able draw the needle 1165 proximally at a controlledrate and is able to retract the needle 1165 by moving the pull 2210distally.

Should the needle 1165 encounter resistance as the pull 2216 isadvanced, such as from a stop mechanism, described above, the shaft 2276will move away from the first end portion 2231 toward the second end2233. Thus, the internal spring 2238 is compressed to avoidover-extension of the needle 1165.

In some embodiments, the pulls 2210, 2216 can comprise slots 2224, 2234,while the shafts 2270, 2276 can comprise tabs 2225, 2235 that have holestherein. Thus, a user may place a tool through the hole in the tab 2225,2235 to move the needle 1161, 1165 directly, without the aid of thepulls 2210, 2216 or the springs 2228, 2238.

Referring to FIGS. 33, 34A, 34B, the suture claps arms 1031A and 1031Bcan be deployed and retracted by movement of actuators 2240 and 2260.The actuators 2240, 2260 can be levers, switches, or rockers. In otherembodiments the actuators 2240, 2260 can have other configurations.

As noted above, the elongate member 1020 can have a plurality of cutouts(not shown) that expose the actuator rods 1035 to permit connection tothe actuators 2240, 2260. Referring to FIG. 15A, the proximal ends ofthe actuator rods 1035A, 1035B extend through the lumens 1026, 1024 ofthe elongate tubular member and terminate at connections to the pulls2240 and 2260 on the suturing device handle 2200 (FIG. 33).

In one embodiment, the actuator rods 1035A, 1035B, which are connectedto the suture claps arms 1031A and 1031B, are also connected to shafts2245, 2265 (FIGS. 34A, 34B), respectively. The proximal ends of theactuator rods 1035A, 1035B can extend from the proximal end of thelumens 1026, 1024, respectively, in the elongate tubular member 1020through opening 2202 into the handle 2200. The actuator rods 1035A,1035B can be exposed by cutouts (not shown) in the elongate tubularmember 1020 for connection to the shafts 2245, 2265, respectively.Referring to FIGS. 34A and 34B, the shafts 2245, 2265 can each have apassage to permit the elongate member 1020 to pass through the shafts2245, 2265. The actuator rods 1035A, 1035B can be connected to theshafts 2245, 2265 directly by a suitable bonding process, or indirectly,such as by connection to small tubes that are adhered to the actuatorrods 1035A, 1035B, for example, by epoxy, which are in turn connected totabs 2246, 2266. The tabs 2246, 2266 can be connected to the shafts2245, 2265, respectively, at notches 2247, 2267 in the shafts 2245,2265. Thus, the actuator rods 1035A, 1035B move according to themovement of the shafts 2245, 2265.

With continued reference to FIGS. 34A and 34B, the handle 2200 cancomprise springs 2251, 2253, 2271, 2273, collars 2252, 2254, 2272, 2274,and followers 2255, 2275. The springs 2251, 2271 can located proximal tothe shafts 2245, 2265 between the housing 2201 the shafts 2245, 2265.The distal springs 2253, 2273 can be located distal to the shafts 2245,2265 between the housing 2201 and the shafts 2245, 2265.

The collars 2252, 2272 can be located proximal to the shafts 2245, 2265,between the proximal springs 2251, 2271 and the shafts 2245, 2265. Thus,the proximal springs 2251, 2271 tend to distally bias the proximalcollars 2252, 2272 against the shafts 2245, 2265.

The collars 2254, 2274 can be located distal to the shafts 2245, 2265between the distal springs 2253, 2273 and the shafts 2245, 2265. Thus,the distal springs 2253, 2273 tend to proximally bias the distal collars2254, 2274 against the shafts 2245, 2265.

With reference to FIG. 34A, the followers 2255, 2275 can each comprise apassage 2258, 2278, shoulders 2259, 2279, and ramps 2257, 2277 (FIG.35). The passages 2258, 2278 can be configured to allow the shafts 2245,2265 to move through the passages 2258, 2278, and the elongate tubularmember 1020 to extend through the followers 2255, 2275. The shoulders2259, 2279 and collars 2252, 2254, 2272, 2274 can be configured suchthat the collars engage the shoulders to prevent the collars frompassing completely through the followers 2255, 2275.

Referring to FIG. 35, the actuators 2240, 2260 can each comprise cams2241, 2261 and pivot pins 2249, 2269. The pivot pins 2249, 2269cooperate with the housing 2201 for pivoting movement of the actuators2240, 2260. The cams 2241, 2261 and the ramps 2257, 2277 of thefollowers 2255, 2275 can be configured such that cams engage the rampsto move the followers as the actuators pivot relative to the housing.

In use, movement of the actuators 2240, 2260 allows the springs 2251,2253, 2271, 2273 to move shafts 2245, 2265 proximally and distally. Forexample, with reference to FIG. 34A, as the actuators 2240, 2260 pivotcounterclockwise about the pivot pins 2249, 2269 (FIG. 34B), thefollowers 2255, 2275 are pushed proximally. As the followers 2255, 2275move proximally, the proximal collars 2252, 2272 are likewise movedproximally to compress the proximal springs 2251, 2271. Proximalmovement of the followers 2255, 2275 also allows the distal springs2253, 2273 to proximally advance the distal collars 2254, 2274. In turn,the distal collars 2254, 2274 proximally advance the shafts 2245, 2265.As described above, the suture clasp arms 1031A, 1031B move with theshafts 2245, 2265. Thus, the suture clasp arms 1031A, 1031B are moved totheir extended positions.

The distal springs 2253, 2273 can be configured such that they will notproximally move the actuator rods 1035A, 1035B beyond the location wherethe suture clasp arms 1031A, 1031B are fully extended, even if theactuators 2240, 2260 move the followers 2255, 2275 far enough to allowfurther decompression of the distal springs. For example, the forceexerted by the distal springs can be insufficient to extend the sutureclasp arms 1031A, 1031B beyond their fully-extended positions. On thecontrary, the springs 2253, 2273 can have sufficient length and applysufficient force to fully extend the suture clasp arms 1031A, 1031B,even if the elongate member 1020 is bent.

With continued reference to FIG. 34A, as the actuators 2240, 2260 pivotclockwise about the pivot pins 2249, 2269 (FIG. 34B), the followers2255, 2275 are pushed distally. As the followers 2255, 2275 movedistally, the distal collars 2254, 2274 are likewise moved distally tocompress the distal springs 2253, 2273. Distal movement of the followers2255, 2275 also allows the proximal springs 2251, 2271 to distallyadvance the proximal collars 2252, 2272. In turn, the proximal collars2252, 2272 distally advance the shafts 2245, 2265. As described above,the suture clasp arms 1031A, 1031B move with the shafts 2245, 2265.Thus, the suture clasp arms 1031A, 1031B are moved to their retractedpositions.

The proximal springs 2251, 2271 can be configured such that they willnot distally advance actuator rods 1035A, 1035B beyond the locationwhere the suture clasp arms 1031A, 1031B are fully retracted, even ifthe actuators 2240, 2260 move the followers 2255, 2275 far enough toallow further decompression of the proximal springs. For example, theforce exerted by the proximal springs can be insufficient to damage theactuator rods 1035A, 1035B or the suture clasp arms 1031A, 1031B oncethe suture clasp arms have reached their fully-retracted positions. Onthe contrary, the proximal springs 2251, 2271 can have sufficient lengthand apply sufficient force to fully retract the suture clasp arms 1031A,1031B, even if the elongate member 1020 is bent.

FIG. 36 illustrates one embodiment of a system for suturing an openingin a vessel wall or other biological tissue, or for performing otherprocedures as described above. The system 3000 can comprise a firstsuturing device 3100 and a second suturing device 4100. While the systemand suturing devices 3100, 4100 will be described in reference tosuturing an opening in the heart wall, such as a patent foramen ovale(PFO), the first suturing device 3100 and the second suturing device4100, either alone or in combination, could be used, like the devices100, 1100, 1100′, to close other openings in the heart wall, such as apatent ductus arteriosus (PDA) or an atrial septal defect (ASD), otheropenings in bodily tissue, or the like. The device 1100 could also beused to suture adjacent biological structures or any other time it maybe desired to apply a suture to a biological structure.

The first suturing device 3100 and the second suturing device 4100 canbe similar to the suturing devices 1100, 1100′ in some respects.Accordingly, components of the first suturing device 3100 and componentof the second suturing device 41000 that are similar to those of thesuturing devices 1100, 1100′ are indicated by similar reference numerals31XX and 41XX, respectively, rather than 11XX. For example, the suturingdevices 3100, 4100 can each comprise an elongate tubular member 3020,4020 having a spreader assembly 3090, 4090 connected to the distal endof the elongate tubular member 3020, 4020. The elongate tubular members3020, 4020 can be similar to the elongate tubular members 1020, 1020′.Likewise, the spreader assemblies 3090, 4090 can be similar to thespreader assemblies 1090, 1090′. A handle 3200, 4200 can be provided atthe proximal end of each tubular member 3020, 4020. The handles 3200,4200 can be similar to the handle 1200 or the handle 2200.

The first suturing device 3100 and the second suturing device 4100 candiffer from the suturing devices 1100, 1100′ in some respects. Forexample, in contrast to the devices 1100, 1100′, the devices 3100, 4100can comprise a single suture clasp arm and a single suture catchmechanism. Accordingly, the elongate tubular members 3020, 4020,spreader assemblies 3090, 4090, and handles 3200, 4200 can be configuredto operate the single suture clasp arm and the single suture catchmechanism, rather than plural suture clasp arms and plural suture catchmechanisms, by omission of those components associated with more than asingle suture clasp arm and a single suture catch mechanism.

The spreader assemblies 3090, 4090 of the devices 3100, 4100 can beshorter than the spreader assemblies 1090, 1090′ because the spreaderassemblies 3090, 4090 may comprise fewer components the spreaderassemblies 1090, 1090′. Therefore, the spreader assemblies 3090, 4090may extend into left atrium less than the spreader assemblies 1090,1090′ when positioned in a PFO.

The first suturing device 3100 can comprise a suture clasp arm 3031A anda suture catch mechanism 3161 (FIG. 39C) operated by a handle 3200having a pull 3210 and an actuator 3240. Referring to FIG. 37, thesuture clasp arm 3031A can comprise a deflecting plate 3099 that isintegrally formed with the suture clasp arm 3031A.

The second suturing device 4100 can comprise a suture clasp arm 4031Band a suture catch mechanism 4165 (FIG. 39G) operated by a handle 4200having a pull 4216 and an actuator 4260. The elongate tubular member4020 and the spreader assembly 4090 can be configured for use of twoguidewires similar to the elongate tubular member 1020′ and the spreaderassembly 1090′. Thus, the spreader assembly 4090 can comprise an opening4043, shown in FIG. 38) through which a second guidewire can extend.

The suture clasp arm 4031B can comprise a guide section 4032, as shownin FIG. 38. The guide section 4032 can assist in maintaining a desiredrotational orientation between the second guidewire and the spreaderassembly 4090. The guide section 4032 can thus assist a user indirecting the second guidewire to a desired location, such as thesuperior vena cava, as the second guidewire is extended from the device4100. Additionally or alternatively, the guide section 4032 can assist auser in positioning the device 4100 in a desired located, such assubstantially centered relative to the septum secundum 6 of the PFO.

The operation of the system 3000 comprising the first suturing device3100 and the second suturing device 4100, described above, isillustrated according to one embodiment in FIGS. 39A-39L in conjunctionwith a procedure for closing a PFO. As shown in FIG. 39A, the distal endof a suturing device 3100 is advanced through the vasculature andpositioned in the tunnel 8 of the PFO between the septum primum 7 andthe septum secundum 6. The suturing device 3100 may be advanced over aguidewire 10 or alternatively delivered through a catheter introducersheath 1011 using techniques which are known in the art.

The suturing device 3100 is initially positioned such that the spreaderassembly 3090 is near the tip of the secundum primum 7 and the sutureclasp deployment arm 3031A is permitted to extend from the spreaderassembly 3090. The suture clasp arm 3031A may then deployed from thespreader assembly 3090 and then the device 3100 is retracted until thesuture clasp arm 3031A extends around the tip of the secundum primum 7,as shown in FIG. 39B, and gathers the tissue of the septum primum 7between the arm 3031A and the spreader 3030.

Once the suture clasp arm 3031A has been properly positioned around theseptum primum 7, needle 3161 may be deployed from the suturing device3100 to penetrate the septum primum 7 and engage the suture clasp arm.The needle 3161 is advanced through a passageway in the suturing deviceand deflected by needle guide 3060A along an angle that intersects thedeployed suture clasp arm 3031A as it exits the suturing device 3100.The needle engages the suture clasp arm 3031A, as shown in FIG. 39C, toengage the suture portion 3052A.

As shown in FIG. 39D, once the suture portion 3052A has been engaged,the needle 3161 and engaged suture portion 3052A are then retractedthrough the tissue of the septum primum 7 into the elongate member 3020of the suturing device 3100. The device 3100 may be advanced slightly sothat the suture clasp arm 3031A can be closed without pinching theseptum primum 7. The first suturing device 3100 may then be withdrawnfrom the vasculature over the guidewire 10.

The second suturing device 4100 may then be advanced through the venousaccess into the tunnel 8 of the PFO between the septum primum 7 and theseptum secundum 6, as shown in FIG. 39E. The second guidewire 1010 canbe advanced through the opening 4043 (FIG. 38) into the superior venacava (FIG. 1). The second guidewire 1010 may be preloaded in the device4100 before introduction of the device 4100 into the body such that adistal end of the second guidewire is near the opening 4043.

The suture clasp arm 4031B can then be extended and the device 4100 canbe advanced such that the suture clasp arm 4031B extends around the tipof the septum secundum 6, as shown in FIG. 39F, and gathers the tissueof the septum secundum 6 between the arm 4031B and the spreader 4030.Alternatively, the suture clasp arm 4031B can be extended from thespreader assembly 4090 before the second guidewire 1010 is advanced intothe superior vena cava. The suturing device 4100 can be configured suchthat when the second guidewire 1010 is advanced into the superior venacava, the second guidewire 1010 directs the device 4100 toward thecenter of the septum segundum 6 as the device 4100 is advanced.

Once the suture clasp arm 4031B and suture portion 4052B have beenproperly positioned around the septum secundum 6, the needle 4165 may bedeployed from the distal end of the suturing device 4100 to penetratethe septum secundum 6 and engage the suture portion 4052B. As shown inFIG. 39G, the tip of the needle 4165 is pulled proximally from alocation distal the suture clasp arm 4031B through the tissue of theseptum secundum 6 towards deployed suture clasp arm 4031B to engage thesuture portion 4052B, as shown in FIG. 39G.

Once the suture portion 4052B has been engaged, the needle 4165 andengaged suture portion 4052B are then retracted distally through thetissue of the septum secundum 6 and into the suturing device 4100, asillustrated in FIG. 39H. The suture clasp arm 4031B may then be closedand thereafter the second guidewire 1010 retracted into the suturingdevice 4100. Alternatively, the second guidewire 1010 can be retractedinto the suturing device 4100 before the suture clasp arm 4031B isclosed. Once the suture clasp arm 4031B is closed, the suturing device4100 may be withdrawn from the patient's heart.

As shown in FIG. 39I, the suture portion 3052A has been positionedthrough the septum primum 7 while suture portion 4052B has beenpositioned through the septum secundum. After the suturing device 4100has been withdrawn, the suture portions 3052A, 3052B, 4052A and 4052Bwill extend proximally from the PFO. The suture portions 3052B and 4052Acan then be secured together, as illustrated in FIG. 39J, by tying aknot according to any known method or by applying a knot by any methodor device that is described or referenced herein. The suture portions3052B and 4052A can be secured together exterior to the body or withinthe body. Any excess portion of sutures 3050 and 4050 can be trimmed.

The suture portions 3052A and 4052B can and can then be pulled to drawthe septum secundum 6 and septum primum 7 towards one another to closethe PFO, as described above. As the sutures 3050, 4050 are pulled tight,the sutures 3050, 4050 preferably cause the septum secundum 6 and septumprimum 7 to turns or folds so that the tip of the septum primum 7extends in the opposite direction compared to the tip of the septumsecundum 6, as shown in FIG. 39K. The knot can be positioned between theseptum primum 7 and the septum secundum 6, as illustrated in FIG. 39K.Such placement of the knot may agitate the tissue and promote healingbetween the septum primum 7 and the septum secundum 6. In oneembodiment, the knot is positioned between the septum primum 7 and theseptum secundum 6, as illustrated in FIG. 39K, by pulling the sutureportion 4052B until the knot is pulled against the septum secundum 6then pulling the suture portion 3052A to those the PFO.

An alternative method of operation of the second suturing device 4100 isillustrated according to one embodiment in FIGS. 40A-40E. Afteroperating the first suturing device 3100 according to the abovedescription of FIGS. 39A-D and withdrawn, the second suturing device4100 may then be advanced through the venous access into the rightatrium 2 of the heart adjacent to the PFO, as shown in FIG. 40A. Thefirst guidewire 10 can be withdrawn from the PFO and advanced into thesuperior vena cava (FIG. 1) before or after introduction of the secondsuturing device 4100. Additionally or alternatively, a portion of thedevice 4100 can be advanced into the superior vena cava.

The second guidewire 1010 can be advanced from the opening 4043 (FIG.38) through the PFO between the septum primum 7 and the septum secundum6. The suture clasp arm 4031B can then be extended and the device 4100can be advanced such that the suture clasp arm 4031B extends around thetip of the septum secundum 6, as shown in FIG. 40B, and gathers thetissue of the septum secundum 6 between the arm 4031B and the spreader4030. Alternatively, the suture clasp arm 4031B can be extended from thespreader assembly 4090 before the second guidewire 1010 is advanced intothe PFO. The suturing device 4100 can be configured such that when thefirst guidewire 10 is advanced into the superior vena cava and thesecond guidewire 1010 is positioned through the PFO, the first guidewire10 and the second guidewire 1010 direct the device 4100 toward thecenter of the septum secundum 6 as the device 4100 is advanced.

Once the suture clasp arm 4031B and suture portion 4052B have beenproperly positioned around the septum secundum 6, the needle 4165 may bedeployed from the distal end of the suturing device 4100 to penetratethe septum secundum 6 and engage the suture portion 4052B. As shown inFIG. 40C, the tip of the needle 4165 is pulled proximally from alocation distal the suture clasp arm 4031B through the tissue of theseptum secundum 6 towards deployed suture clasp arm 4031B to engage thesuture portion 4052B.

As shown in FIG. 40D, once the suture portion 4052B has been engaged,the needle 4165 and engaged suture portion 4052B are then retracteddistally through the tissue of the septum secundum 6 and into thesuturing device 4100. The device 4100 can then be retracted slightly topermit the suture clasp arm 4031B to closed. Thereafter, the secondguidewire 1010 can be retracted into the suturing device 4100.Alternatively, the second guidewire 1010 can be retracted into thesuturing device 4100 before the suture clasp arm 4031B is closed. Oncethe suture clasp arm 4031B is closed, the suturing device 4100 may bewithdrawn from the patient's heart.

As shown in FIG. 40E, the suture portion 3052A has been positionedthrough the septum primum 7 while suture portion 4052B has beenpositioned through the septum secundum. After the suturing device 4100has been withdrawn, the sutures 3050 and 4050 can be used to draw theseptum secundum 6 and septum primum 7 together to close the PFO, asdescribed above.

Although the operation of the devices 3100 and 4100 has been describedwith reference to two sutures 3050, 4050, the devices 3100, 4100 can beused in some embodiments to place a single suture through both theseptum primum 7 and the septum secundum 6, or to place multiple suturesthrough each of the septum primum 7 and the septum secundum 6. In someembodiments, plural devices 3100, plural devices 4100, or both can beused to place multiple sutures through one or both of the septum primum7, the septum secundum 6, or other biological tissue, biologicalstructure, prosthetic, or synthetic material or implantable device inthe body. For example, plural devices may be used to suture a prostheticheart valve to the heart or to affix a balloon, umbrella, or otherdevice that is not properly positioned to the surrounding tissue.

Although the foregoing description of the preferred embodiments of thepresent invention has shown, described and pointed out the fundamentalnovel features of the invention, it will be understood that variousomissions, substitutions, and changes in the form of the detail of theapparatus as illustrated as well as the uses thereof, may be made bythose skilled in the art, without departing from the spirit of theinvention. For example, while the suturing device is described withrespect to closing a patent foramen ovale in a patient's heart, it isfurther envisioned that the suturing device could used to close orreduce a variety of other tissue openings, lumens, hollow organs ornatural or surgically created passageways in the body. The suturingdevice may have any suitable number of arms, such as two or four ormore, and any given arm may have one or more suture clasps or openings.

1. A system for suturing a patent foramen ovale, comprising a firstsuturing apparatus and a second suturing apparatus; the first suturingapparatus comprising: a first elongate body having a proximal end and adistal end; a first suture clasp arm adapted to hold a first suture endportion, the first suture clasp arm being extendable from said body froma retracted position to an extended position and configured to be placedaround a septum primum of the patent foramen ovale, wherein the firstsuture clasp arm is the only suture clasp arm of the first suturingapparatus; a first suture catch mechanism slidably housed in saidelongate body, the first suture catch mechanism being moveable in aproximal to distal direction through the septum primum of the patentforamen ovate to engage a distal end of the first suture catch mechanismwith the first suture end portion held by the first suture clasp armwhen the first suture clasp arm is in the extended position; and a firstguide configured to deflect the first suture catch mechanism when thefirst suture catch mechanism moves in the proximal to distal direction;and the second suturing apparatus comprising: a second elongate bodyhaving a proximal end and a distal end; a second suture clasp armadapted to hold a second suture end portion, the second suture clasp armbeing extendable from said body from a retracted position to an extendedposition and configured to be placed around a septum secundum of thepatent foramen ovale, wherein the second suture clasp arm is the onlysuture clasp arm of the second suturing apparatus; a second suture catchmechanism slidably housed in said elongate body, the second suture catchmechanism being moveable in a distal-to-proximal direction through theseptum secundum of the patent foramen ovale to engage a distal end ofthe second suture catch mechanism with the second suture end portionheld by the second suture clasp arm when the second suture clasp arm isin the extended position; and a second guide configured to deflect thesecond suture catch mechanism when the second suture catch mechanismmoves in the distal-to-proximal direction.